Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- Success in the pharma industry hinges on adopting unified platforms, real-world evidence (RWE), health economics and outcomes research (HEOR), and genomics.
- New delivery models can optimize clinical trial execution by migrating to next-generation platforms and automating business processes. Our highly skilled clinical data management (CDM) professionals employ these models to address and fulfill customer requirements adeptly.
- Our scalable, flexible, and cost-effective services work well with an organization’s existing processes and can be tailored to their unique business needs.
- We rigorously uphold compliance with the Clinical Data Interchange Standards Consortium (CDISC) and relevant customer-specific standards.
In this article
Overview
Investments in infrastructure, software, and talent upskilling are essential to keep pace with technology transformations.
The pharmaceutical industry must transform CDM to address the challenges of integrating multiple data sources by adopting unified platforms. As the role of the data manager evolves to that of a data scientist, more pharma companies emphasize data integrity and the use of next-gen electronic data capture (EDC) tools, data warehouses, and non-CRF data integration in clinical trials.
A complete suite of systems (seamless with limited or no integration) in one CDMS integrating multiple data sources (e-source, HEOR, electronic medical records, digital data, electronic patient-reported outcomes) is crucial for companies today.
Keeping pace with these expectations, TCS’ data managers elevate into clinical data scientists by performing trend analysis with increased scientific rigor and real-time data reviews using advanced analytics.
Solution
TCS’ CDM services focus on delivering high-quality clinical trial data.
Given the evolving needs of the pharma industry, we offer standards-driven CDM services, incorporate smart study build, ensure direct data transfer to EDC, and embed intelligent queries with risk-based data management.
Our study start-up services include the development of a data management plan, eCRF specifications, edit check specifications, database design, edit check programming, external checks or listing programming, case report form (CRF) completion guidelines, quality control management, and user acceptance testing. TCS adheres to coding guidelines for WHODrug Dictionary (WHODD) and MedDRA, undertaking essential dictionary set-up tasks to ensure compliance in our processes.
Our study conduct services suite covers data review and query management, data entry and verification, third-party data transfer and reconciliation, ePRO data handling, medical coding, serious adverse events (SAE) reconciliation, medical data review, study data transfers, archival, and the like.
As part of the study closeout phase, we collaborate closely with customers and offer support for database and regulatory audits, interim database closure and lock, project closure documentation, study data transfer, archival, and decommissioning.
Additionally, TCS offers specialty services, such as automation consulting, digital clinical trials (DCT) technology-led services, smart questionnaires (ePRO, e-diaries), smart devices and wearables, and proficiency in medical device data management.
Tailoring our approach to a study's unique needs, customers can opt for either of the operating models, such as the end-to-end study-based model, milestone-based model, or FTE (full-time equivalent) model. Collaborative synergy across domains like clinical operations, biostatistics programming, and medical writing has delivered superior data outcomes.
Benefits
We offer a holistic approach to quality and compliance with an inspection readiness team.
First-time right (FTR) approach - TCS uses an agile methodology, with practices such as collective work management, transparency, real-time interventions, and collective wisdom, and embraces change to drive quality and efficiency.
In-house training team – Pharma Academy of Learning and Sharing (PALS) has created industry-benchmarked modules on therapeutic areas, diseases, and molecules. This enhances the scientific understanding of CDM project teams before they are assigned the studies.
TCS’ CDM projects have delivered upper quartile performance by significantly reducing median cycle times (for the final protocol to go live and last-patient-last-visit to database lock). We offer multiple cost-effective models to manage life sciences companies’ clinical development portfolios.
The TCS Advantage
TCS is committed to driving transformation through technology innovations and industry-standard solution accelerators.
We have demonstrated deep domain expertise in CDM for the past two decades across all our engagements, including projects for multiple top global pharmaceutical companies.
TCS’ experienced talent pool reflects knowledge depth across phase I to phase IV, expertise in 20 therapeutic areas, and has handled clinical studies with complex disease indications.
Our agile, lean, experienced, and adequately resourced teams assure delivery excellence commitments by mitigating risks and challenges. Our leadership position in capability and experience in the life sciences domain, IT, and R&D brings unique transformative solutions to the CDM landscape.
We have developed over 25 process automations within CDM by deploying AI-ML, and RPA bots developed on UiPath and Automation Anywhere and have partnered with leading technology providers to stay on top of CDMS products.
We have rich technical expertise with unified platforms, reporting tools, electronic clinical outcome assessments (eCOAs), and DCT platforms. These complement our proprietary solutions to provide end-to-end CDM services.
Case in point: Driving operational excellence
The model provides more accountability to improve upper quartile (UQ) performance for a global top UK-based pharma customer.
The adoption of agile methodology by the CDM project team helped our customer achieve and exceed upper quartile performance of data management milestones.
The customer required a transparent approach to enhance cycle times for priority studies and to elevate operational excellence by redefining accountabilities.
Our CDM project team successfully deployed the agile methodology to comprehend role inter-dependencies and establish clear ownership, facilitating on-the-go recalibration and ensuring FTR delivery.
Notably, the customer was able to experience a significantly reduced cycle time from eleven weeks to five weeks from last subject last visit (LSLV) to database lock (DBL). TCS was instrumental in helping the customer improve UQ performance from 59% to 82% within a short period.