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Adjudication

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Ensuring Consistency & Accuracy of the Study Results To Effective Adjudication Processes

We deal with all the adjudication process complexities to ensure that your studies are efficiently executed while complying with the regulatory requirements.

With TCell, you have access to a sophisticated end-to-end electronic adjudication process.

Guided by experts and supported by experience, our clinical endpoint adjudication services ensure that your studies are always trusted for accuracy, transparency, and compliance.

Extensive Experience 93% 93%
Always Available Intelligence 87% 87%
Improved Efficiency 78% 78%

What do Our Clients & Partners say?

We have worked with an extensive eco-system of pharmaceutical companies, sites, and CRAs, for their Phase 2 & Phase 3 trials and have managed studies with a few hundred to tens of thousands of patients. Their voice is the best proof of our capabilities.

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
Medical Writing

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
Data management team

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

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.