genproresearch

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SUBX is an intelligent submission tool developed by Genpro that help sponsors to better prepare for their NDA/PMDA submissions. As Sponsor is preparing for their NDA submission, it is critical for them to verify the content and validity of the dataset folder per the FDA submission requirements. Datasets must meet the technical specifications per the Study Data TCG and eCTD validation criteria. Our submission validation framework will check whether the datasets that are provided for regulatory publishing is compliant to the FDA/EMEA guidance.

https://genproresearch.com/subx/

#subx #clinical trail

[genproresearch]

SUBX is an intelligent submission tool developed by Genpro that help sponsors to better prepare for their NDA/PMDA submissions. As Sponsor is preparing for their NDA submission, it is critical for them to verify the content and validity of the dataset folder per the FDA submission requirements. Datasets must meet the technical specifications per the Study Data TCG and eCTD validation criteria. Our submission validation framework will check whether the datasets that are provided for regulatory publishing is compliant to the FDA/EMEA guidance.

https://genproresearch.com/subx/

[genproresearch]

BASICS OF BAYESIAN STATISTICS – SERIES II

Prior distribution

In Bayesian models, the prior distribution is viewed as an essential portion and is usually based on the data from previous trials. Priors can be informative or uninformative and it shows the strength of beliefs about the parameters. The posterior is determined by the data (data-driven) when the prior is uninformative and the posterior is a mixture of the prior and the data when the prior is informative. The selection of prior should be deliberate and careful since the choice of the prior distribution can be highly subjective and can affect the final results substantively.

Likelihood principle

In Bayesian inferences, there are two types of quantities, observed and unobserved. Observed quantities are the data and an unobserved quantity includes parameters, missing data, future observations, etc which may have occurred in the past, or yet occur in the future. The likelihood functions play a central role in statistical inference. Assume that the parameter in a clinical trial is represented by the Greek Letter θ (“theta”). Then the likelihood function states that all the relevant information for making inference on θ is contained in the observed data and not in other unobserved quantities. It is a mathematical representation of the relationships between observed outcomes and the parameter θ and expressed as f(data/θ)

Posterior probabilities

The main goal of Bayesian analysis is to obtain the model posterior distribution of parameters. The posterior probability is the probability that an event that will occur after all the substantive information or evidence has been taken into account and is closely related to the priors. Posterior probability can be obtained by updating the prior probability using Baye’s theorem.

Predictive probability

One of the benefits of the Bayesian approach is that predictive inference is a straightforward computation once the posterior distribution has been obtained. Bayesian methods allow for the derivation of the probability of unobserved outcomes given what has already been observed. This probability is called the predictive probability. The predictive distribution is the distribution of all possible unobserved values conditional on the observed values. In clinical trials the posterior distribution is used to determine when to stop a trial (based on predicting outcomes for patients not yet observed), predicting a clinical outcome from an earlier or more easily measured outcome for that patient, model checking, etc.

Exchangeability of trials

The concept of exchangeability allows for more flexible modeling of most experimental setups. Exchangeability offers to change two factors without affecting the results. When the previous trials considered have good prior information, then the Bayesian clinical can assume another level of exchangeability. That is the trial can be assumed to be exchangeable with other previous trials which enable the current trial to “borrow strength” from the previous trials while acknowledging that the trials are not identical in all respects. Exchangeable trials can be thought of as a representative sample of some super-population of clinical trials. Bayesian hierarchical models are used to implement the exchangeability of trials and the exchangeability of patients within trials.

Decision rules

The decision rule tells what action is to be taken based on observed input. One common type of decision rule is the traditional hypothesis testing. For Bayesian, it considers that a hypothesis has been demonstrated (with reasonable assurance) if the posterior probability is large enough1.

REFERENCE

Comment, Public. “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.”

Image Courtesy – Department of Statistics, Penn State

Original Source:   https://genproresearch.com/knowledge/basics-of-bayesian-statistics-series-ii/

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Genpro Medical & Scientific Writing can provide a wide array of regulatory and scientific writing services for Pharmaceuticals, Biotech, and Medical Device domains. Our experienced writers are capable of working effectively cross-functionally and across different geographies. They are trained to provide quality deliverables in record timelines while keeping the compliance at the core. Genpro MSW maintains the robust processes which are agile enough to be customized based on the need for the region or therapeutic focus. Integration of Genpro MW with other essential line functions like biostatistics and programming is backed by innovative AI-ML based tools.

#medical writing #scientific services #cro #Clinical Research

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Voody is a cognitive search and extraction platform for clinical research documents. The user will be able to create clinical trial search spaces into which, trial related documents like protocol, SAP, TMF contents and external research articles can be uploaded.

https://bit.ly/2TUoPjd

#Clinical Data visualization tools #clinical trial data management #AI in medical writing #Medical Writing Services #Bayesian Adaptive design #R programming in clinical trials

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MOSS is a clinical data analysis and visualisation tool which makes use of Natural Language Processing and Deep Learning algorithms to automatically translate a natural language (English) question from a clinician to a structured database query. MOSS will then render the output in an aesthetically appealing form (charts, graphs, tables, tokens) and will also allow drill down analysis on these reports. MOSS allows clinicians and trial monitors to reduce their dependence on the data team to do ad-hoc visualisations and analysis of key risk indicators. MOSS will also provide statistical analysis plugins in future releases so that the clinicians will be able to perform basic data analysis.

[genproresearch]

MOSS is a clinical data analysis and visualisation tool which makes use of Natural Language Processing and Deep Learning algorithms to automatically translate a natural language (English) question from a clinician to a structured database query. MOSS will then render the output in an aesthetically appealing form (charts, graphs, tables, tokens) and will also allow drill down analysis on these reports. MOSS allows clinicians and trial monitors to reduce their dependence on the data team to do ad-hoc visualisations and analysis of key risk indicators. MOSS will also provide statistical analysis plugins in future releases so that the clinicians will be able to perform basic data analysis.

#clinical biostatistics services #clinicalresearch

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VOODY-Automating Medical & Scientific Literature Search, Review & Authoring

Voody is a semi-automated platform that enables the researchers to search, filter, author, review, and publish scientific and medical documents. Voody’s machine-assisted document processing and information extraction combined with seamless integration of PubMed reduce cognitive overload for researchers up to 70%. Voody’s automated information source citing and linking to the context document eases the review process for researchers. Integrated QC module in VOODY provides fast and easy validation of the document before publishing. Voody also provides a single searchable repository of all the documents that are produced through this process.

#Clinical Data visualization tools clinical trial data management clinical biostatistics services Statistical Programming services Regulatory

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Genpro makes it simple for pharmaceutical companies to realize the real potential from Artificial Intelligence and Machine Learning (ML). We support Sponsors and CROs to build, adopt, utilize and implement competent AI & ML solutions that drive better research outcomes.

#ml #ai #clinical research #clinical data

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Genpro brings together the global best practices in Clinical Data Management, Biostatistics, Programming, Medical Writing and Strategic Consulting. Our products use AI/ML & NLP to accelerate clinical research

#clinical research #strategic consulting

[genproresearch]

SUBX is an intelligent submission tool developed by Genpro that help sponsors to better prepare for their NDA/PMDA submissions. As Sponsor is preparing for their NDA submission, it is critical for them to verify the content and validity of the dataset folder per the FDA submission requirements. Datasets must meet the technical specifications per the Study Data TCG and eCTD validation criteria. Our submission validation framework will check whether the datasets that are provided for regulatory publishing is compliant to the FDA/EMEA guidance.

#subx #nda #pmda

[genproresearch]

GenPro offers expert consulting services on complex statistical issues encountered during study design or analysis. We provide guidance in incorporating and analysing the effectiveness of statistical methodologies in clinical trials with a great deal of expertise in adaptive designs and Bayesian analysis. Our biostatisticians possess the experience and critical thinking to assist clients. They are industry experts in several statistical areas including adaptive design, personalised medicine, Bayesian analysis and non-inferiority approaches with extensive experience in several indications. Genpro team has been working for more than 15 years in NDA/ BLA/PMA submission and interacting with FDA/ EMEA and PMDA and actively collaborate with academic, industry and FDA working groups. We are well versed with CDISC data standards and electronic submission standards to deliver high quality, dependable analyses.

#data management #biostatistics #biostatistics services

[genproresearch]

We deliver consulting services in the areas of Biostatistics, Statistical programming, FDA interactions and Regulatory interactions. At Genpro we have an experienced and dedicated team of developers with detailed knowledge of all phases across the drug development spectrum. We assure customized, fully validated deliverables by working closely with biostatisticians to build and deploy your trial. Genpro provides clinical data mapping and data conversion services whereby legacy data is mapped to new data standards ensuring compliance with changing standards.

#biostatistics #statistical programming

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Genpro offers an experienced team of clinical data managers and clinical data coordinators who comes with a life science background. They are trained in ICH/GCP as well as CFR PART 11 guidelines. Genpro has extensive experience in various EDC tools and provides EDC setup services to different phases of clinical trials. As part of these services, we have acted as the data management centre and supervised the Data Collection, Query Management, Data Cleaning and Database lock. Genpro prepares a comprehensive data management plan (DMP) which is a road map to handle the data under foreseeable circumstances and describes all the CDM activities to be followed in the trial. We have also been part of several data monitoring committees which oversaw the process with various sponsors.

#cdm #data management #clinical data management