Clinical Data Management (CDMS) - TCell Clinical Services

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

Technology, Processes, and Experience, the Three Pillars of Quality Clinical Data

Our deep understanding of operational aspects of clinical trials and therapeutic areas has helped deliver quality data consistently.

Our clinical data managers provide you with the optimal solution for your clinical trial that will allow your study to manage the data efficiently without compromising data quality or integrity. We provide comprehensive data management activities from database build, through data cleaning and query resolution, to database lock and archival.

Automated Analytics 97%
Intelligent Insights 85%
Efficient Data Processing 80%

Technology Capabilities

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 database snapshots
Quality and efficient database lock

What do Our Clients Say?

We adopt a proactive and collaborative approach to provide you with optimal clinical data management solutions and services. With our robust technology-enabled practices, you get efficient and effective solutions.

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

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

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.

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.