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Innovative And Technology Enabled Clinical Development And Data Management Services

Our experienced team, collaborative approach, intelligent use of advanced technology, and a strong urge to bring value to our client are the pillars of our success.

Technology
We not only use cutting-edge, secure, and robust off-the-shelf technology solutions but have our proven applications to support you.
Adjudication
With TCell, you have access to sophisticated end-to-end electronic adjudication processes along with our expertise in managing adjudication in large outcome studies.
Clincial Data Management Services
Our deep understanding of operational aspects of clinical trials and therapeutic areas has helped deliver quality data consistently through our comprehensive data management services.
We help pharmaceutical and biotech companies to better manage clinical trials by providing modern cloud-based electronic Trial master file (eTMF) solutions.
ETMF Solutions
We provide professional and efficient medical writing services using automated technology solutions for complete and accurate documentation of your clinical studies.
Medical Writing
Our biostatistics offers efficient upfront study design and comprehensive planning assistance, along with a deep understanding of the science of disease areas and compounds.
Biostatistics

Technology Capabilities

As technology evolves, we are bringing intelligence to the services we deliver through the successful applications we have developed. We bring an unparalleled advantage for our clients through a perfect blend of technology, clinical & pharma domain expertise, experience, and skills.

Our technology-based service delivery through our clinical development solutions enables you to achieve clinical trial automation by employing the concepts of Machine Learning (ML) and Artificial Intelligence – AI in clinical trials. Intelligent clinical trials result in a better quality of results and data and increased efficiency for you. We help you automate the entire life-cycle of clinical studies, which apart from clinical trial automation also includes medical writing automation and narrative automation.

As a result, you have a better drug delivery and clinical studies pipeline that ultimately gives you a competitive edge.

Clinical Data Management Services (CDMS)

We provide end-to-end CDMS powered with the help of our experienced team of clinical scientists, statisticians, and analysts. From setting up the Clinical Database to Data Analysis and Reports Generation, the team ensures efficient service delivery through our automated technology solutions.

  • Rapid database creation
  • The integration of clinical data sources and efficient review through automated intelligent data solutions (ClinSights)
  • Medical coding by experts
  • Robust query management and resolution process
  • Effective external vendor data management
  • Aggressive database lock time line, clean and quality clinical trial data.
  • Regulatory Compliant Processes and Submission Documents

The TCell Advantage

  • Get started quickly through our automated processes & solutions
  • Support decentralized or multicenter trials
  • Ensure high-quality data by reducing manual intervention in data management
  • Automatically capture data from multiple sources, collate, and analyze it
  • Efficient and accurate submission-ready reports and documents
  • Real-time reporting, data export, and visual, multi-dimensional data analysis

What Do Our Clients Say?

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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Medical Writing

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

ETMF Solutions

ETMF Solutions

  • Our comprehensive reports help you track the accurate statuses of informed consents CVs Ethics committee approvals electronic case report forms financial disclosures and more which results in better productivity and compliance from study start to submission/archival.
  • Archiving allows any part or the entire eTMF repository to be securely exported to DVD or other media for independent offline review by independent auditors quality consultants or non-users.
  • Archives may be stored encrypted or for long term archiving stored unencrypted on DVD securely.
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ETMF Solutions

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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