TCS Clinical Operations Services

Life science companies need timely access to accurate and consistent data across the clinical trial lifecycle, in order to secure regulatory approvals faster, boost operating efficiency, and prevent recalls. This requires automation of their business processes spanning various phases of the research studies, for trials to be completed in time–without any cost overruns.

Tata Consultancy Services’ (TCS’) Clinical Operations Services, covering the entire trial lifecycle, facilitate convenient, real-time access to relevant data through workflow automation. Our ValueBPS approach enables companies to secure regulatory approvals faster, reduce drug development costs, and ensure full compliance with trial-related standards.

The TCS Advantage

Our ValueBPS approach harnesses our deep domain expertise and operations redesign methodologies such as FORE. Our approach also encompasses robotic process automation (RPA), analytics and insights, our unique IT-BPS synergy, Business Process as a Service (BPaaS) models, and business process management (BPM). ValueBPS helps enterprises improve process efficiency, data accuracy, and scalability of operations.

  • Industry Domain Expertise: Our subject matter experts have up to 15 years of experience in successfully implementing support services across the clinical trial lifecycle, including site selection, monitoring, and project management. TCS’ team of more than 200 domain consultants has worked on a broad array of trial activities involving study setup, conduct and records management.
  • Delivery Excellence: Since 2007, we have successfully handled clinical support services for leading pharmaceutical and biotech firms globally. Our teams manage daily updates and trial documentation for more than 1,000 studies. We verify the backgrounds of over 5,000 investigators every month, with SLA compliance of 99%.
  • Robotic Process Automation: Our self-learning, non-intrusive robots are developed to address every possible business process scenario. Pharmaceutical companies have increased productivity, accuracy, and compliance by deploying these robot components that integrate domain-specific standards and compliance requirements.

Solutions We Offer

Our services cover the following key aspects of clinical trials:

  • Study Startup Support: Verifying investigator background, fostering release of investigational products through evaluation of IP release packages, activating sites, assisting in submissions to ethics committees.
  • Study Conduct Support: Provisioning real-time, updated data across clinical trial management systems (CTMS), drug shipment records systems, and financial disclosure management systems; backing long-term follow-up (LTFU) studies.
  • Study Records Management: Implementing electronic trial master file (eTMF) systems for document management; collecting, uploading, reviewing and reconciling essential documents (EDs); updating trial registries without compromising on data secrecy.

Benefits

TCS Clinical Operations Services help pharmaceutical, biotechnology and medical device companies reap the following benefits:

  • Shortened Trial Lifecycle: Ensure faster drug approvals by reducing the turnaround time for trial completion by 80% to 90%, and achieving 95% accuracy in study data.
  • Higher Cost Efficiency: Lower drug development costs by bringing down manual oversight to the tune of 90%.
  • Regulatory Compliance: Adhere to relevant rules concerning site audits, industry protocols, and good clinical practices (GCP); maintain up-to-date records and submit accurate drug safety reports in a timely manner.

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