Electronic Trial Master File

Electronic Trial Master File

Methods of Capturing the data  clinical trials.

Electronic Trial Master File (eTMF) solution is a clinical collaboration platform for managing the Data of Subject, Activity, Tracking, Maintaining, Archiving clinical trial documents. It allows life sciences companies to streamline processes, automate information exchange, and reduce the administrative overhead associated with running clinical trials.

What EDC Gives:

  • eTMF Process Management and Workflow of the Activity Wise Management
  • In an eTMF,
Electronic Trial Master

Real time management of Trial documents

The TMF has historically been composed primarily of paper documents, images in physical file cabinets.

In order to lower costs and to expedite the clinical trials approval processes, government agencies involved in regulating clinical trials such as the U.S. FDA and the EMA have been developing technology for the same.

This would also lower the costs of the approvals of clinical trials processes.

Electronic Data Capture in Biznet

Methods of Capturing the data  clinical trials.

When researchers conduct a clinical study, they collect information about their patients using Case Report Forms (CRFs).

After the conduction of clinical Trials or BA/BE studies the large numbers of forms like CRF, Protocol, ICD, Insurance Policy, Source documents, Master documents were required for the study as well as the Audit purpose for the regulatory.

Biolyte for Bioanalytical Solution

Biolyte for Bioanalytical Solution

Introduction:
The development of the bioanalytical techniques brought a progressive discipline for which the future holds many exciting opportunities to further improvement. The main impact of bioanalysis in the pharmaceutical industry is to obtain a quantitative measure of the drug and its metabolites. The purpose is to perform the pharmacokinetics, toxicokinetic, bioequivalence and exposure response like Various bioanalytical technique performed in bioanalytical studies such as hyphenated techniques,

Why Smart R (IWRS) in Clinical Research?

Clinical research and the pharmaceutical industry have been exponentially expanded throughout the first decade of the 21st century in terms of drug revelations, their inventions, several medical devices, and other technologies to assist the community better in health care. 

This accelerated boom has put pharmaceutical industries under enormous pressure to win the race by getting their drugs in the market and getting them patented.

clinical trials for efficient patient care

Software use for efficient patient care in clinical trials

A new test product and treatment both aren’t sold in the market directly. Before the sell, it needs to be tested on research subjects for efficacy, safety, tolerability of different dosage forms and diseases studied for this whole process is called a Clinical Trial.

In the whole process of conducting clinical trials there are some necessary approvals required from the applicable regulatory,

Clinical Trial Challenges & Opportunities

Clinical Trial Challenges & Opportunities

Advances in IT combined with business model transformation could combine to form a critical step in attaining transformation of the Clinical Trial Enterprise through lower cost, faster, and better data excellence of clinical trials. The entities involved in the conduct of clinical trials have not followed the cost-reduction route of other technology-intensive industries and thus have not attained a business transformation adequate to gain the economic benefits of technologic adoption.

Understanding-of-data-capturing-in-standardized-CDISC-SDTM-format

Understanding of data capturing in standardized CDISC-SDTM format

An Electronic Data Capturing (EDC) or Direct Data Capture (DDC) for collection of clinical data through computerized system helps accelerating and streamlining the data collection method by replacing the traditional paper based CRF, in an organized and standardized process. But mapping raw Electronic Data Capture (EDC) data to a Study Data Tabulation Model (SDTM) or Analysis Data Model (ADaM) standard is a very time consuming process.

Electronic Data Capture for BA-BE Studies

End-to-end electronic data capture solution for clinical trial operations

Research & Development industries like Pharmaceuticals, Biotechnology, Life Sciences, Device industries etc. invest their big chunk of resources into managing their operations for numerous lines. Many CROs outsource and hire consultants to complete the projects followed up with submissions to regulatory bodies in various regions. It’s been seen that different department would have different vendors [...]
Clinical Data using technology as a solution in setting benchmark

Clinical Data using technology as a solution in setting benchmark

It has become a practice now to avoid data slip through cracks, where CROs have been continuously evolving by moving towards technology as a solution for their data capturing from scratch to the end report. Recent findings in tech world has highlighted the power of machine learning algorithms and their impact on Clinical Trials company assaying bigger capabilities to ensure data integrity and quality.

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Regulatory compliant, multi-functional Clinical trials management software solution for CROs

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