What We Do

Clinical data management and Data entry

At TCell, we aim to deliver top quality clinical data by employing latest technology, standard processes and experienced data management team. Our team has decades of experience in managing clinical data from Phase I to IV in different Electronic data capture systems and legacy paper CRF models across several therapeutic areas.

 

Technology:

  • 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 are able to start-up studies within 4-8 weeks

 

Data management team:

Our deep understanding of operational aspects of clinical trial and therapeutic areas has helped deliver quality data consistently. We offer complete data management services that include:

  • Selection and building of Electronic Case Report Forms (eCRFs) and sophisticated validation checks
  • Establish comprehensive data management and data handling plans
  • Investigator meeting presentations and training
  • Setting of third party vendors
  • Ongoing third party and SAE reconciliation
  • Industry standard clinical coding
  • Support interim and DMC data base snapshots
  • Quality and efficient database lock

 

Adjudication:

Pharmaceutical companies may establish endpoint or adjudication committee to review the study safety or efficacy endpoint, particularly when the end points are subjective and or complex. The adjudication process is quite complex as it involves the sites, sponsors, end point coordinators, access and languages of source records.  In addition, with large outcome studies sponsors obtain approval for study end points to be exempted for SAE reporting until the events are adjudicated. However health authorities require the adjudication process to be completed within reasonable time to avoid delays in adverse/serious adverse event reporting. Hence there is cost, complexity and regulatory commitment that requires adjudication process to be set-up carefully from study initiation.

With Tcell, you have access to sophisticated end-to-end electronic adjudication process along with our expertise in managing adjudication in large outcome studies. This facilitates quicker turnaround time and quality adjudication packages that are incompliance with health authority requirement.

We also work closely with the sites and CRAs to ensure endpoint packages are submitted in a timely fashion and you will have continued access to status of end point reporting and adjudication.

 

eTMF solutions:

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

Our electronic solutions provide documents in submission-ready format. Our comprehensive reports help you track the accurate statuses of informed consents, CVs, ethics committee approvals, electronic case report forms, financial disclosures  and many more, which results in better productivity and compliance from study start to submission/archival.