Medical writing services using automation

Regulatory and Clinical Writing By Experienced Professionals

Attention to quality and compliance to the rigorous scientific standards are the vital components of medical writing. Our experienced writers with healthcare and pharmaceutical knowledge and background turn your data into an accurate and evidence-based representation of the clinical profile of your drug.

At TCell, we uniquely leverage intelligent and automated technology solutions for our service delivery. Our edge is evident through our product Jnarratives which provides you with an automatic, efficient, and intelligent way to build your submission-ready narratives at just a click of a button. JNarratives help you with clinical trial automation to ensure you are efficiently completing your clinical studies.

Aided by our collaborative approach, extensive experience, and in-depth, hands-on knowledge of medical writing requirements, we deliver high client satisfaction every time.

Our writers and peer reviewers, who are healthcare professionals, work closely with clients, which results in clinical trial documents that are the highest level of scientific rigor.

Our medical writing team has worked with significant Pharmaceutical, Biotech, and Medical device companies and supported numerous trials, ranging from Phase II to Phase IV.

Quality Documentation

Regulatory Compliance

Medical Writing Automation

What Do Our Clients Say?

We work closely as an extended team of our clients. Such a highly collaborative approach, coupled with adherence to scientific rigor, ensures that our clients get accurate and well-presented, compliant documentation every time.

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

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

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.