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ccrpsorg · 1 year

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Decentralized Clinical Trials and Contract Research Organizations in 2023

Decentralized Clinical Trials for the CRO

Decentralized clinical trials (DCTs) are a relatively new concept in the world of clinical research, but they are quickly becoming more popular. In 2023, DCTs are expected to become even more widely used as the technology and infrastructure needed to support them continues to develop.

A decentralized clinical trial is one that is centered around patient needs and improves the patient experience by allowing them to participate from their own homes or local healthcare providers. This type of trial eliminates the need for patients to physically access hospital-based trial sites, which can be difficult for some people due to distance or other factors. It also allows for greater flexibility in terms of scheduling and data collection, as well as improved accuracy of results due to fewer potential sources of error.

In addition to these guidelines from the FDA, there are several ethical considerations that must be taken into account when conducting a decentralized clinical trial. These include ensuring patient privacy and confidentiality, providing informed consent forms that clearly explain the risks associated with participating in a DCT, and ensuring that all participants have access to appropriate medical care if needed during the course of the study.

How CROS can Implement DCTs

Contract research organizations (CROs) can implement decentralized clinical trials by modifying their protocol to incorporate remote data collection, patient-centric protocols, and virtual engagement between trial participants and CRO personnel. Remote data collection allows for the capture of participant-generated data outside of a traditional clinical setting via digital devices. Patient-centric protocols allow for a more personal approach to clinical trials by allowing patients to participate in activities such as self-reporting on symptom severity, digitally submitting medical images and lab results, and engaging with physicians from the comfort of their own home. Virtual engagement between trial participants and CRO personnel can be facilitated through secure video conferencing tools that enable real-time interactions.

Further modifications to the CRO protocols could also include integrating artificial intelligence technology into the trial process such as automated monitoring of patient behavior, prioritizations of interventions based on individual risk profiles, and remote health guidance by virtual nurses or other healthcare professionals. Mobile applications could also be used to remind participants about upcoming appointments or events related to the study as well as remind them about taking medication or completing questionnaires. Incorporating these types of technologies would ensure that decentralized clinical trials are conducted efficiently while providing participants with an enhanced user experience throughout every step of the trial process.

Five Steps to Implementing Decentralized Clinical Trials

1.Educate Project Managers: Contract research organizations (CROs) should ensure that their project managers are educated about the benefits of decentralized clinical trials and how to go about implementing them. This could include learning about the technology, regulations, data privacy, and other important elements related to this type of trial design.

2. Establish Data Security Measures: Before conducting a decentralized clinical trial, CROs should have strong data security measures in place to protect participants’ information and ensure that it is secure throughout the study duration. This includes accessing participant data only with permission and using encryption protocols when transmitting or storing any sensitive information.

3.Evaluate eClinical Platforms: A key part of implementing decentralized clinical trials is choosing the right eClinical platform for your study design. CROs should evaluate the various eClinical platforms available to them and select one that meets their needs for a successful trial, such as being user friendly for participants, having features such as remote monitoring capabilities, offering robust reporting capabilities, and providing easy access to data from multiple sites.

4.Utilize Mobile Technologies: To make a decentralized clinical trial successful, leveraging mobile technologies can be extremely helpful for CROs to communicate with volunteers remotely, manage participant engagement in real-time, collect patient-reported outcomes quickly and accurately from anywhere, track compliance with protocols on site visits or assessments done remotely, etc., reducing the need for face-to-face visits whenever possible.

5. Create Protocols: Having clear protocols in place is essential if a CRO wants to successfully implement decentralized clinical trials as they help ensure consistency across different sites by setting expectations around communication between sites and central teams; supervision of staff; quality control procedures; safety reporting; use of investigational drugs; collection of patient data; follow up on withdrawals or lost patients; etc., throughout the duration of the trial

How do DCTs Work?

Decentralized clinical trials offer a variety of benefits to CROs, such as reduced costs associated with traditional on-site trials, improved patient recruitment, faster data collection and analysis, and greater efficiency.

Decentralized clinical trials (DCTs) offer a promising new model for contract research organizations (CROs). By leveraging decentralized technologies such as blockchain and distributed ledger technology, DCTs provide a secure, efficient, and cost-effective alternative to traditional CRO models.

The key advantages of DCTs for CROs include enhanced security and data integrity, improved consent management, faster and more secure patient recruitment, and greater visibility into the trial process. With DCTs, CROs can leverage existing research infrastructure while streamlining processes such as data management and quality control.

To further explore the potential of DCTs, it's helpful to look at some recent developments in the industry. In 2018, Decentralized Clinical Trials LLC partnered with Johnson & Johnson to create JLABS@TMCx to develop innovative digital health solutions for clinical trials. This collaboration unveiled two major projects that leverage decentralized technologies: Project Catalyst and Project Ovenbird.

Project Catalyst seeks to develop a system of protocols that will allow researchers to securely exchange information in real-time. The project is currently focused on developing decentralized application (dApp) versions of standard protocols and applications used in clinical trials. Meanwhile, Project Ovenbird seeks to create an enterprise-grade distributed data platform that will enable researchers to collect structured data from decentralized sources while maintaining privacy standards comparable to those set by HIPAA.

In addition to these projects with J&J, Decentralized Clinical Trials LLC has also partnered with Microsoft Corporation on a pilot program called "Verified Credentials." This program leverages blockchain technology to ensure accurate identity verification during patient recruitment processes for clinical trials.

For CROs interested in exploring DCTs further, there are several resources available online that can help provide a better understanding of their benefits, applications, and potential challenges. The National Institutes of Health recently launched the Decentralized Clinical Trials Hub (DCThub), which provides educational materials about DCTs for research professionals. Additionally, several companies offer products tailored specifically for DCTs such as TrialX from OptumIQ or Oneyield from Castor EDC Solutions Ltd., both of which are designed to support decentralized clinical trial design and implementation workflows.

Types of Remote Monitoring in DCTs

Decentralized clinical trials are conducted using remote monitoring technology to capture data from patients rather than requiring them to come into a physical research site. This allows for more flexible trial designs that can be tailored to specific patient populations and geographic locations. In addition, patients can more easily participate in a trial without having to travel or take time off from their daily lives. For example, virtual visits through telemedicine can be used for initial screening and assessments, reducing the number of visits required at an on-site research facility.

Data collected from decentralized clinical trials is often more accurate than what is typically collected in traditional on-site trials due to the use of continuous wearables, mobile devices and other innovative digital technologies that provide real-time monitoring of health parameters such as blood pressure or glucose levels. This increases the quality and granularity of information available to researchers while decreasing the amount of labor required for data collection. Additionally, electronic health records (EHRs) can be integrated with decentralized trial platforms allowing for rich longitudinal datasets that enable deeper insights into patient outcomes over time.

One example of a decentralized clinical trial is the use of telemedicine to support remote monitoring. This could involve providing video conferencing for patient-physician visits and using smartphones for tracking vital signs. In addition, telemedicine can enable doctors to monitor patients with chronic conditions remotely, by collecting medical data from sensors that have been placed on the patient’s body. This type of monitoring allows doctors to keep track of changes in health parameters without requiring an in-person visit, significantly reducing both costs and risks associated with traveling for treatment.

Another example is direct-to-patient (DTP) trials, in which medication is shipped directly to a patient's home instead of them having to travel to a clinic. In this case, study coordinators can monitor the progress remotely via phone calls or text messages while also providing support when needed. This approach has enabled researchers to conduct studies involving large numbers of participants located around the world who would otherwise not have been able to participate due to geographic distance or lack of transportation resources.

Finally, wearable devices are also being used increasingly in decentralized clinical trials as they allow researchers to collect more accurate data about activity levels and other health metrics over long periods of time without needing frequent interventions from healthcare personnel. It is possible for these devices to be connected directly with electronic data capture systems so that the collected information can be analyzed quickly and accurately by researchers.

Larger Patient Engagement

The decentralization of clinical research also opens up new opportunities for CROs to reach larger populations by enabling simultaneous studies across multiple sites around the world and removing many logistical barriers related to travel or geographical distance between participants and study sites. Additionally, leveraging social media platforms for recruiting further expands access potential outside of traditional recruitment networks and offers ways to engage with potential participants more directly than before.

Decentralized clinical trials, also called virtual studies or remote research, have the potential to revolutionize the way clinical studies are conducted. A decentralized clinical trial is a type of clinical study where participants are distributed across geographical and other boundaries, allowing them to participate from their own homes or from one of many remote sites.

To explore further options regarding DCTs and related technologies, interested parties may consult companies such as Medidata Solutions (www.medidatasolutionsinc.com), IMS Health (www.imshealth.com), HRA Pharma (www.hrapharma) or IQVIA (www.iqvia). These firms specialize in providing comprehensive services related to DCT implementation, ranging from development and customization of software solutions through full project management services that cover all aspects of a clinical trial operation from start-up through completion – including training protocols for implementing these new technologies at each site visited during study duration and beyond..

Overall, decentralized clinical trials represent a significant opportunity for CROs looking to move away from costly on-site studies in favor of more cost effective approaches that offer equally robust data sets but require fewer resources from both researchers and participants alike. As technology continues to advance so too will our collective ability to take advantage of decentralized trial designs for bigger impact studies without sacrificing quality or rigor.

Decentralized clinical trials offer many advantages over traditional site-based studies. They provide greater convenience for patients while still maintaining high levels of safety and efficacy standards. As technology continues to advance in 2023, we can expect even more opportunities for DCTs to become available.

More Examples on Decentralized Clinical Trials:

In the past decade, the advent of blockchain and other technologies have made it possible for clinical trials to be conducted in a decentralized manner. Here are five examples of decentralized clinical trials currently taking place across the world.

1. Mediledger Clinical Trial Supply Chain: This trial is being managed by MediLedger, a healthcare-focused blockchain consortium. The goal of this trial is to use blockchain technology to streamline and secure the global movement and tracking of drugs within the supply chain. The solution will enable parties to share data about patient safety, drug expiration dates, and more in real-time – all while remaining compliant with regulatory standards.

2. CardiLynx Smart Phone ECG Readings: This study is being conducted by CardiLynx, a healthcare technology company that specializes in mobile health applications that measure electrocardiograms (ECGs). The aim of this trial is to use an app on a smartphone to accurately detect heart arrhythmias in patients over time, as well as identify early symptoms and risk factors associated with cardiovascular diseases like stroke and heart attack.

3. Cogstate Cognitive Testing Trial: This study is sponsored by Cogstate, an AI-powered cognitive assessment platform that uses computer games to measure cognitive performance across multiple disciplines such as memory, attention and executive functioning. The purpose of this trial is to evaluate how well Cogstate’s technology can accurately detect changes in cognition over time in various patient populations and disease states.

4. Takeda Whole Genome Sequencing Study: This research project is sponsored by Takeda Pharmaceuticals, one of the world’s largest pharmaceutical companies. In this project, researchers are using whole genome sequencing technology to increase our knowledge about genetic mutations related to certain diseases such as hemoglobinopathies or rare blood disorders. They are also trying to identify new treatment options based on these mutations that could help improve patient outcomes overall.

5. Verily Life Sciences Patient Health Monitoring Project: This project involves Verily Life Sciences working with healthcare providers, payers and employers on an initiative called “Project Baseline” which uses wearables and other devices such as Fitbits or Apple watches to monitor patients’ health data in real-time while they go about their daily lives outside of a clinical setting. Through this project, Verily aims to understand how different lifestyle behaviors can influence health outcomes; enhance patient engagement; reduce healthcare costs; and ultimately improve population health management globally

6. GlaxoSmithKline’s digital platform trial: GlaxoSmithKline developed an innovative digital platform to conduct a clinical trial of its new asthma drug, mepolizumab, in the United States. The trial involved recruiting participants through a web-based interface, using secure electronic data capture (EDC) tools to collect and store data in real time, and utilizing mobile devices for remote patient monitoring. This decentralized clinical trial was able to reduce the traditional costs associated with running a large-scale clinical trial because it eliminated many of the steps required for enrollment and data collection. Additionally, it enabled GSK to recruit more geographically diverse participants who would not have been able to take part in a conventional trial setting.

7. Merck's MyEHRConnected study: Merck conducted the MyEHRConnected study, which sought to evaluate the efficacy and safety of its diabetes medication Januvia (sitagliptin). This was an international phase III study that utilized electronic health records (EHRs) from more than 60 sites located throughout Europe, Asia Pacific, Latin America and Canada in order to identify eligible patients with type 2 diabetes. The EHRs enabled Merck to recruit participants quickly without requiring physical visits or extensive paperwork. Furthermore, researchers could securely access patient data stored within the EHR system during the duration of the study for analysis and evaluation purposes—a process that would have been impossible with paper-based records.

8. Sanofi's Telcare Diabetes Trial: Sanofi conducted a revolutionary telephone-based randomized control trial known as the Telcare Diabetes Trial (TDCAT), which aimed to assess the impact of telemedicine on diabetes care management among patients at risk for complications due to uncontrolled blood sugar levels. Patients were randomly divided into two groups—one group received standard care while another group received a combination of traditional care plus remote support provided by nurses through weekly phone calls over a period of six months. Results showed that those participants receiving telemedicine services had significantly better glycemic control than those who did not receive any telemedicine services at all—highlighting one powerful benefit of decentralizing clinical trials using technology such as telephone communication services.

9. Novartis’wearable device clinical trial: Novartis launched an ambitious clinical trial involving 20,000 individuals across nine countries in order to evaluate whether wearable devices such as smart watches can detect early signs of heart failure before medical symptoms appear. The decentralized nature of this study offered numerous advantages over traditional studies in terms of cost savings as well as recruitment speed; enabling Novartis to rapidly reach out potential participants worldwide instead of relying solely on localized recruitment methods used previously by other companies conducting similar trials with much smaller sample sizes due to limited resources or geographic restrictions

10. Eli Lilly & Company's eCOA Study: Eli Lilly & Company recently completed an innovative eCOA (electronic Clinical Outcomes Assessment) study that leveraged mobile applications and internet-connected devices in order to record patient outcomes over longer periods of time compared with traditional studies involving paper forms or periodic clinic visits alone. By using this decentralized approach, Lilly was able to gather more accurate data while reducing costs associated with running conventional trials; making it possible for them to enroll larger numbers of patients in shorter periods than ever before.

11. The IQVIA-sponsored study by the Alzheimer's Prevention Initiative (API). This study was designed to evaluate the effects of an investigational oral form of the drug solanezumab on the cognitive decline associated with early stage Alzheimer's disease. It was a decentralized trial conducted using remote monitoring, which allowed participants and clinical sites to interact online via web-based video visits, digital questionnaires and remote diagnostic testing. The trial collected data from over 800 participants at over 30 clinical sites in 12 countries.

12. A decentralized clinical trial launched by Durect Corporation to assess its investigational drug DUR-928 for the treatment of nonalcoholic steatohepatitis (NASH). The Durect NASH study was conducted across 16 countries and used innovative telemedicine technologies for patient monitoring and data collection. In addition to traditional site visits, remote video visits were performed with patients and caregivers to observe adverse events, review patient-reported outcomes, analyze lab results remotely and monitor compliance with the protocol.

13. The Institute for Qualitative Medicine’s (IQM) pilot study that evaluated an innovative approach to decentralizing clinical trials using mobile health technology (mHealth). The mHealth platform was used to connect participants remotely with healthcare professionals who monitored vital signs such as blood pressure, heart rate, respiratory rate, oxygen saturation level and body temperature using wireless medical devices connected directly to smartphones or computers. In addition, the platform included a chatbot that trained participants on how to use their medical device correctly or send real-time reminders when it was time for follow-up appointments or tests.

14. An analysis conducted by PPD Incorporated comparing decentralized vs centralised clinical trials for a Phase IIb study evaluating an investigational vaccine for malaria prevention in children aged 1–6 years old. They found that decentralizing the trial saved approximately 25% in total resources spent compared to a centralized approach and resulted in shorter recruitment times due to increased convenience for both investigators and participants alike compared with centralised approaches where people had to travel long distances for appointments or procedures.

15. A global Phase IIIa research program sponsored by GSK which evaluated an experimental shingles vaccine involving over 17000 elderly individuals across 11 countries in Europe and Latin America including Argentina, Brazil, Chile, Colombia, Germany Spain France Italy Netherlands Poland Portugal UK..The study incorporated various decentralized models such as virtual/remote clinic visits with self-administered questionnaires through smartphones/tablets; home delivery of intervention product; remote diagnostics; online physician/patient communication through video calls; collection of sample storage through kits sent remotely from local courier companies etc., thus enabling a truly distributed model of conducting clinical trials without relying solely on physical presence at site locations

Want to train your staff to run decentralized clinical trials? Enroll them in our in-depth clinical trial certification courses with hours of lectures focuses on remote monitoring alone.

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octalsoft · 3 months

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Navigating the Complexities: Challenges of Site-Centricity in Medical Trials

The landscape of medical trials is evolving rapidly, with a profound shift towards enhanced levels of patient centricity in clinical trials. However, despite this progression, challenges persist, particularly in the realm of site-centricity.

Site-centricity refers to the traditional model where clinical trials are primarily conducted at physical sites such as hospitals, clinics, or research centers. While this approach has its advantages, it also presents a myriad of challenges that can impede the efficiency, cost-effectiveness, and inclusivity of medical trials.

The Significance of Site-Centricity

The question of what is patient centricity in clinical trials has long since been answered but Site-centric trials are now increasingly gaining gravitas. They offer a controlled environment, access to specialized equipment, and oversight by trained professionals, ensuring data accuracy and patient safety.

Moreover, they foster collaboration among investigators and provide a structured framework for trial execution. However, the dependence on physical sites brings forth a set of formidable challenges that cannot be overlooked.

Geographical Limitations

One of the most evident challenges of site-centric trials is the geographical limitations they impose. Patients participating in these trials must often travel long distances to access specific sites, causing inconvenience and financial strain. This limitation hampers recruitment rates and results in a lack of diversity among participants, potentially affecting the generalizability of trial outcomes.

Furthermore, rural or remote populations face heightened barriers, often lacking access to trial sites altogether. This disparity contributes to underrepresentation, affecting the applicability of research findings to these communities.

2. Patient Recruitment and Retention

Recruiting and retaining participants in site-centric trials pose substantial hurdles. Limited awareness about trials, coupled with the inconvenience of frequent site visits, deters many potential candidates from enrolling or completing the trial. This challenge is exacerbated by strict eligibility criteria, further narrowing the pool of eligible participants.

Moreover, maintaining patient engagement and adherence to the trial protocol becomes challenging over extended periods. Patients may face difficulties in balancing trial commitments with their daily lives, leading to dropouts and compromising the integrity of trial results.

3. Cost and Time Inefficiencies

Site-centric trials often incur substantial costs associated with site setup, infrastructure, and personnel. The need for physical space, equipment, and staff can significantly inflate the overall expenses.

Additionally, prolonged timelines due to recruitment delays, administrative processes, and logistical issues escalate the costs further, leading to budget overruns and delayed drug approvals.

4. Regulatory Compliance and Data Quality

Compliance with stringent regulations and ensuring data integrity are pivotal in clinical trials. However, site-centric trials encounter difficulties in maintaining consistent protocol adherence across multiple sites.

Variability in data collection methods, documentation practices, and adherence to protocols among different sites can compromise the reliability and quality of the collected data.

5. The Emergence of Decentralized Clinical Trials

Recognizing the limitations of site-centric trials, the concept of decentralized clinical trials (DCTs) has gained traction.

DCTs leverage technology to decentralize various trial components, minimizing the reliance on physical sites. These trials offer a promising solution to many challenges posed by site-centricity.

6. Virtual Engagement and Remote Monitoring

DCTs leverage telemedicine, wearable devices, and digital platforms to facilitate remote patient monitoring and data collection.

This approach allows patients to participate from the comfort of their homes, eliminating the need for frequent site visits. Virtual engagement enhances convenience for participants, potentially improving recruitment rates and retention while reducing geographical barriers.

7. Enhanced Diversity and Inclusivity

By transcending geographical constraints, DCTs have the potential to achieve greater diversity among participants.

Remote participation enables the inclusion of individuals from various geographic locations and demographic backgrounds, enhancing the representativeness of trial populations and the generalizability of findings.

8. Data Integrity and Real-Time Insights

The integration of digital tools in DCTs enables real-time data collection and analysis. Continuous monitoring and instant data feedback enhance the quality and timeliness of information, allowing for early identification of trends or adverse events. Moreover, centralized data collection minimizes discrepancies and ensures consistency across the trial, enhancing data integrity.

9. Regulatory and Ethical Considerations

While DCTs offer numerous advantages, they also present unique regulatory and ethical challenges. Issues related to data privacy, patient consent, and the validation of remote data collection methods necessitate careful consideration and adaptation of regulatory frameworks to accommodate these innovative trial designs.

Conclusion

The evolution from traditional site-centric trials to decentralized approaches represents a paradigm shift in medical research. While site-centricity has been foundational, its limitations in terms of geographical constraints, patient recruitment, cost inefficiencies, and data quality necessitate a transformation in trial methodologies.

Decentralized clinical trials offer a promising avenue to overcome these challenges, fostering inclusivity, enhancing data quality, and revolutionizing the landscape of medical research by incorporating some of the best site-centricity platforms Embracing innovation while addressing regulatory and ethical considerations will be pivotal in harnessing the full potential of decentralized trials and advancing medical knowledge for the benefit of patients worldwide. Want to know more about how Octalsoft’s eClinical suite can help you overcome the challenges of site-centricity? Book a demo with us now!

#patient centricity in clinical trials #patient centricity clinical trials #challenges of site centricity

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crbtech-arun · 7 months

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Recent Trends in Clinical Research: What's New in 2023

Clinical research is a dynamic field that continually evolves to meet the demands of advancing healthcare, technological innovations, and regulatory changes. As we step into 2023, the landscape of clinical research is marked by a series of transformative trends that promise to shape the future of healthcare. In this article, we'll explore the latest developments in clinical research and shed light on the growing prominence of clinical research companies in Bangalore, India.

1. Decentralized Clinical Trials (DCTs)

One of the most significant shifts in clinical research is the increasing adoption of decentralized clinical trials. Traditional clinical trials often require patients to visit physical research sites, which can be challenging for some participants. DCTs leverage technology to facilitate remote data collection, patient monitoring, and even medication delivery. These trials improve patient access, reduce dropout rates, and provide more comprehensive and real-world data.

Clinical research companies in Bangalore are actively embracing DCTs, harnessing the city's reputation as a hub for technological innovation. With a thriving IT ecosystem and a strong focus on healthcare, Bangalore is poised to lead the way in implementing decentralized clinical trials.

2. Artificial Intelligence (AI) and Machine Learning

AI and machine learning are revolutionizing clinical research. These technologies are streamlining various aspects of the research process, from patient recruitment and data analysis to drug discovery. AI-driven algorithms can analyze vast datasets, identify patterns, and accelerate the identification of potential drug candidates.

In Bangalore, renowned for its vibrant tech industry, numerous clinical research companies are at the forefront of AI and machine learning applications in healthcare. They are developing innovative solutions to optimize clinical trial design, predict patient outcomes, and personalize treatment regimens.

3. Real-World Evidence (RWE)

Real-world evidence is gaining prominence as a valuable complement to traditional clinical trial data. RWE leverages data from electronic health records, wearables, and other sources to provide insights into a drug's effectiveness and safety in real-world scenarios. This trend is crucial in facilitating faster drug approvals and more precise treatment recommendations.

Clinical research companies in Bangalore are actively working on RWE initiatives, collaborating with healthcare providers and technology companies to harness the vast troves of data generated in the region's healthcare ecosystem.

4. Patient-Centric Approaches

A growing emphasis on patient-centricity is reshaping the clinical research landscape. Researchers are recognizing the importance of involving patients in study design, recruitment strategies, and decision-making processes. This approach not only enhances patient engagement but also leads to more meaningful and relevant research outcomes.

Bangalore-based clinical research companies are aligning with this trend by implementing patient-centric practices. They are employing innovative communication tools and platforms to ensure patients are active participants in the research journey.

5. Virtual Reality (VR) and Augmented Reality (AR)

Virtual reality and augmented reality are finding applications in clinical research, particularly in patient education, training, and data visualization. These immersive technologies enhance the understanding of complex medical concepts, improve training for healthcare professionals, and enable researchers to visualize and interact with data in novel ways.

In Bangalore, a burgeoning tech startup scene is driving the development of VR and AR solutions for clinical research. These innovations hold the potential to revolutionize medical education, clinical trial design, and patient engagement.

6. Regulatory Advances

Regulatory agencies are increasingly open to innovative trial designs and data sources. The use of digital endpoints, such as smartphone apps and wearable devices, is gaining acceptance. This flexibility is accelerating the drug development process and allowing for more efficient and patient-friendly trials.

Clinical research companies in Bangalore are navigating these regulatory changes adeptly, leveraging their expertise to design and execute trials that meet both global and local regulatory requirements.

7. Sustainability in Clinical Trials

Sustainability is a growing concern in clinical research. The pharmaceutical industry is exploring ways to reduce the environmental impact of clinical trials by minimizing paper usage, optimizing supply chains, and reducing travel-related carbon emissions.

Bangalore, often referred to as the Silicon Valley of India, is home to a cluster of environmentally conscious companies. Clinical research firms in the region are aligning with sustainability trends by adopting eco-friendly practices in their operations and trial execution.

8. Gene and Cell Therapies

The field of gene and cell therapies is experiencing remarkable growth. These therapies hold the potential to treat previously incurable diseases by targeting the root causes at the genetic level. Clinical research in this area is expanding rapidly, with numerous trials underway to assess the safety and efficacy of these innovative treatments.

Clinical research companies in Bangalore are actively involved in gene and cell therapy research, leveraging their expertise in biotechnology and genomics to advance these groundbreaking therapies.

9. Global Collaborations

The globalization of clinical research continues to be a dominant trend. Collaboration among research organizations, pharmaceutical companies, and academic institutions across borders is essential for conducting large-scale trials and accessing diverse patient populations.

Bangalore's international connectivity and reputation as a healthcare and technology hub make it an attractive destination for global collaborations in clinical research.

10. Data Security and Privacy

As clinical research becomes increasingly data-driven, ensuring the security and privacy of sensitive patient information is paramount. Stringent data protection measures and adherence to regulatory guidelines are essential to maintaining trust and compliance in clinical research.

Clinical research companies in Bangalore, known for their robust data security infrastructure, are playing a crucial role in developing and implementing data protection strategies to safeguard patient information.

Conclusion

The field of clinical research is undergoing a profound transformation in 2023, driven by advancements in technology, changing regulatory landscapes, and a growing emphasis on patient-centricity. Bangalore, with its vibrant ecosystem of clinical research companies and its alignment with emerging trends, is poised to lead the way in shaping the future of healthcare through innovative research and development. As these trends continue to unfold, the promise of improved treatments, enhanced patient experiences, and a healthier future becomes increasingly tangible.

If you are searching for a clinical research course in Bangalore then CRBtech is the best corporate training institute in Pune. It has focused on training candidates in IT, Mechanical, Electrical,Civil and Clinical Research. It helps students to start their career journey with a good beginning in the industry.

#education #clinical research

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reportwire · 2 years

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Decentralized Clinical Trials Can Achieve Net Financial Benefits of 5X to 14X

What You Should Know: – New data from Tufts and Medable reveal on average, decentralized clinical trials (DCTs) are associated with reduced clinical trial timelines and can achieve net financial benefits ranging from five to 14 times for Phase II and Phase III trials, respectively. – The findings are based on financial modeling and analysis of trial data from the Tufts Center for the Study of…

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mortallyhauntedfire · 3 years

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Changing objectives of clinical trials covered in clinical research courses

Clinical research courses primarily focus on the different objectives that are followed in diverse clinical trials. They tell students as well as aspiring clinical research professionals how to conduct these trials in an effective and efficient manner. Yet, we cannot guarantee that the same methods will fulfill our objectives. It may be due to some limitations faced in the conduct of these clinical trials. Hence, one needs to come up with different alternatives in response to these problems. One of them is decentralized trials that are included in clinical research courses.

Consequences of not completing recruiting goals taught in clinical research courses

It is a known fact that patient recruitment is an important part of the trial procedure. Hence, this portion is covered in detail during clinical research courses. When professionals do not balance recruiting processes and patient retention, it does impact the trial results. The professional would observe that there would be huge gaps in data obtained from either research studies or clinical trials. In addition to that, it misrepresents the overall patient population and can lead to unfair results. Since this outcome is a possibility, it is always included by industrial experts in clinical research courses.

What is a solution to this problem? Covered by clinical research courses

One of the main problems that are faced by clinical research professionals is that of patient attrition. This fact would also be confirmed by various industry experts to students during clinical research courses. Yet, the field has managed to come up with a solution to this problem which is decentralized trials (DCT). Therefore, this is bound to be included in clinical research courses

The importance of decentralized clinical trials (DCTs)

There are two reasons as to why decentralized clinical trials (DCTs) are important in this time period. Firstly, decentralized clinical trials (DCTs) could prevent the problems of patient attrition. Secondly, DCT’s let sponsors conduct trials that are reasonable to patients with diverse socioeconomic backgrounds. Professionals get to learn on how they could make trials easy for patients in clinical research courses.

https://www.technobridge.in/clinical-research-course.html

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octalsoft · 5 months

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Clinical Operations: What It is and Why It's Important - Octalsoft

The role of clinical operations in the drug development lifecycle, as well as the technologies that may be used to speed the process while preserving compliance.

Clinical operations, sometimes known as ClinOps, ensure that patients receive the best possible treatment. Apart from that, the clinical operation includes compliance with regulatory criteria and standards.

In the United States alone, there are about 23,000 clinical operations managers. While these experts and their teams are at the core of clinical trial success, understanding their position within a healthcare institution is not always straightforward.

This article aims to explain what clinical operations are and why they are important. So without further ado, let’s get to it.

Why are Clinical Operations Important?

Clinical operations are an essential component of the healthcare ecosystem since they ensure that the services provided by a healthcare organization are effective. The operations department strives to ensure that all clinical personnel and patients have everything they need to work effectively together and that the process runs smoothly.

These teams can be particularly useful during the drug development lifecycle. Following the completion of discovery and preclinical research, the clinical development phase begins. Clinical trials and volunteer studies are conducted during this stage to establish that the medicine is safe for human use. ClinOps plays a critical role in ensuring the success of such studies.

It is vital to distinguish between clinical operations and clinical development. Read a client case study on clinical trial design to learn more about clinical development versus clinical operations.

Common Activities and Responsibilities in Clin-Ops

Several operational functions in the healthcare business are handled by this team. These are some examples:

Patient Flow: Patient flow refers to how patients progress through a clinical experiment. To prevent damage, ensure that all healthcare personnel adhere to safety standards and rules.

Quality Assurance: clinical operations monitoring to verify that the trial satisfies the criteria of regulatory authorities. Chart audits, clinical peer review programs, and quality improvement teams are examples of QA tools.

Apart from those specific responsibilities, every clinical operations staff member must be aware of what is trending in healthcare and how those trends may affect procedures in the future.

3 Trends Impacting Clin-Ops

What trends should companies be aware of in order to better support the patient journey and conduct more effective trials? These are just a few examples:

1.Changes in Technology and Delivery of Care

Data growth and technological advancements are having an impact on healthcare. The digital health market is predicted to reach almost US$660 billion by 2025, with a compound annual growth rate (CAGR) of about 25%.

Organizations must understand how this affects the clinical trial process. It's also an opportunity to find new methods to streamline clinical supply operations and harness all of the data that we now have access to through clinical monitoring and operations.

2.Increasing Decentralization

The advantages of decentralized clinical trials were clear during the epidemic, and they are likely to remain so. DCTs and their associated clinical operations software can help pharmaceutical firms receive the information they need better and quicker, and ClinOps has mechanisms in place to keep up with the pace of change.

3.Impact on the Patient Experience

People desire to be more involved in their healthcare and to have their concerns heard. This is great news for clinical studies, as now people are more interested in participating. Time and effort must be invested in enhancing the clinical trial experience from beginning to end to centralize clinical trial operations. Notwithstanding the difficulties associated with decentralized health care, individuals stand to profit from a health system that provides them with more options.

Tools that Ensure Success in Clinical Operations

Numerous different clinical operations tools assist in ensuring various areas of clinical operations success, including compliance, better patient retention, and investigator satisfaction.

EDC and EHR systems can provide real-time clinical decision support, people management, and other tasks.

Role-based credentialing and access mechanisms guarantee that information is only seen (and understood) by those who should see it.

HIPAA compliance practices or software to maintain compliance during the trial process.

Insight management technologies, such as asynchronous engagement and artificial intelligence, assist teams in identifying patterns or areas of concern.

Several tools may be used depending on the activities of your individual healthcare or pharmaceutical firm. While identifying and mitigating compliance difficulties is the most important part, patient retention is also key to successful trials.

In Summation

ClinOps may lack the thrill of clinical science or the glitz of marketing. But, because of its breadth, it has a little bit of everything. ClinOps teams work in research, medical, project management, operations, marketing, legal, regulatory, and data management.

At the end of the day, Clinical Operations is responsible for the actual (and crucial!) task of completing the last stage of drug development. A step that, if done correctly, can alleviate the agony of hundreds to millions of patients now and in the future. Octalsoft has already begun to step into the future with a full array of eClinical software solutions. Do you want to know how Octalsoft can help you overcome current clinical trial problems, speed the discovery of novel therapeutics, and usher in a new age of evidence-based medicine that helps patients worldwide? Book a demo with us now!

#clinical operations software #centralize clinical trial operations

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