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ETMF Solutions

Home What We Do ETMF Solutions

Transparency and Compliance Through Technology

We help pharmaceutical and biotech companies better manage clinical trials by providing modern cloud-based electronic Trial master file (eTMF) solutions. These solutions provided sponsors ongoing and instant access to trial documentation at every point in a trial’s set-up, execution, and archival.

Comprehensive, end-to-end solutions that put all data for your clinical trials at your fingertips. 

Our eTMF solutions enable you access to data about the entire clinical trial lifecycle, from consent forms to the documents for regulatory submission. With electronic & digital signatures compliant with 21 CFR Part 11 requirements, we help you with everything you require in a capable eTMF solution.

Leveraging Automation 89% 89%
Domain Expertise 96% 96%
Technology Capabilities 83% 83%

What do Our Clients Say?

Superior technology-based innovative solutions are what sets us apart from others. Our robust solutions ensure security, audit trail, and complete transparency of all clinical study records. Our clients trust us for that.

It was pleasure working with Tcell, they worked along with us, and helped us meet our timelines and it was a wonderful experience, we would say.
Pharma Company, Data management
We are very pleased with TCells approach to Database design is most intuitive we have seen and queries are so clear. It has been a breeze!!
Large Pharmaceuticals, Site/CRA
TCell Database start-up timelines and database lock timelines are the best we have seen in the industry. Helped us meet our timelines and within in today’s SaaS based EDC systems.
Mid-Size Pharma Company, Data management
With TCell’s team members we feel that they are part of our organization and their dedication in ensuring we meet our stakeholders meeting is something we haven’t seen recently
Small Biotech, project management

Medical Writing

Medical Writing

Our medical writers prepare clear, well-written documents designed to exceed expectations regarding both content and formatting. Our pharmaceutical product development service follows a highly collaborative approach, and it ensures our customer needs are met with the highest quality.

We offer a comprehensive suite of post-approval medical writing services, including:

  • Clinical Trial Protocol
  • Sample size reports
  • Clinical Study reports
  • Clinical Narratives (JNarratives)
  • Literature searches
  • Dossiers
  • Manuscripts
  • Abstracts
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Clinical Data Management

Clinical Data Management

  • We employ CDISC certified and CDASH compliant cost-efficient standard electronic data capture (EDC) solutions that help deliver high-quality data.
  • Our reporting tools offer comprehensive reports that help improve productivity during study conduct and database locks.
  • Our technology also supports ongoing data review and risk-based monitoring that ensures compliance of SOPs and enables reductions in research costs.
  • We can start-up studies within 4-8 weeks
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Biostatistics

Biostatistics

  • Our global clinical biostatistics and programming team offers a deep understanding of the science of disease areas and compounds as well as provide efficient upfront study design and comprehensive planning assistance that helps in:
  • Pharmaceutical product development planning Sample Size estimations study design and analysis as well as supporting methodologies and statistical analysis plans
  • Clinical protocol development Case report form and Clinical study report review
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Biostatistics

Adjudication

Adjudication

  • Access to the sophisticated end-to-end electronic adjudication process
  • Expertise in managing adjudication in extensive outcome studies
  • We also work closely with the sites and CRAs to ensure endpoint packages are submitted in a timely fashion. You will have continued access to the status of endpoint reporting and adjudication.
  • We have successfully managed both efficacy and safety adjudication in phase 2 and phase 3 trials ranging from a few hundred patients to 10000 pts including paper and electronic adjudication.
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Adjudication