For the life sciences industry, clinical trials are the foundation for introducing new drugs, medical devices and vaccines in the market. However, with clinical trial and site management often accounting for over 60% of the drug development cost, enterprises are under pressure to implement lean and efficient clinical trial processes. Compounding this challenge is the usage of paper TMFs, especially when approval from different regulatory bodies, each with their own guidelines, is needed. Paper TMFs lead to inefficiencies in information archival and searching while adding to standardization and logistical challenges, all amounting to delays in the approval process.
Our Solution | Benefits | TCS Advantage
TCS' Remote Clinical Trial Site Monitoring solution enables the efficient remote monitoring of clinical trials. Built on Oracle WebCenter Content and WebCenter Portal platforms, our solution is compatible with leading content management systems. By providing a platform that allows clinical trial staff to upload trial documents, the solution enables CRAs to remotely review trial documents and closely collaborate with trial staff. Our offering incorporates industry standards and best practices to facilitate the creation of eTMFs and associated workflows, thus promoting data quality and integrity. With enhanced CRA efficiency, and reduced organizational risk, our solution accelerates time to market for new drugs.
Leverage TCS' Remote Clinical Trial Site Monitoring solution for the effective remote monitoring of your clinical trial sites to:
- Enhance sales revenues: Increase your CRAs' efficiency by empowering them to review key clinical trial documents uploaded to the platform and resolve data discrepancies anytime, anywhere. Rapidly identify problems and risks at trial sites remotely, and initiate corrective actions, thus reducing time to complete trials and achieving faster time to market. Decrease trial costs – Reduce your trial costs by conducting site visits only when high risk sites are identified, reducing travel cost and duration of stay at clinical trial sites. With the industry formulating standards to create and transmit eTMFs to meet stricter regulatory guidelines, ease your adoption of eTMFs with our offering to:
- Reduce overhead: Move away from paper-based TMFs, lessen paper usage and alleviate storage and maintenance difficulties, improving your organization's resource utilization.
- Improve regulatory compliance: Identify missing documents, centralize governance of all documents by the sponsor, and retain documents necessary to comply with regulations. Respond to regulatory queries quickly with enhanced information access, enabling faster verification of trial results, and consequently, faster drug approval and time to market.
The TCS Advantage
TCS' extensive expertise in life sciences and Oracle technologies including WebCenter Content and WebCenter Portal make us the ideal partner for enhancing the efficiency of your clinical trial processes. We add value to the engagement through our:
- Comprehensive solution: We leverage our expertise in end to end solutions, from defining your organization's process roadmap to global deployments to post-implementation support, while ensuring delivery excellence and adherence to timelines.
- Domain expertise: With an extensive pool of consultants including physicians, pharmacologists, IT architects and professionals, our comprehensive service offerings deliver measurable benefits.
Clinical services Knowledge Process Outsourcing practice, and specialized medical device design and engineering skills coupled with research capabilities in computational biology and chemistry enrich your outsourcing initiatives.
- Industry alliances and technology expertise: We are a trusted partner to leading global life sciences companies and are recognized by Oracle as a Platinum Cloud Premier-level partner in Oracle’s Partner Network (OPN).
- Proven assets and solutions: TCS' life sciences products and frameworks offer best practices and faster solution deployments with reduced risks. Our solutions spanning the entire life sciences value chain not only address industry challenges but also help organizations seek and realize new opportunities.