Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- Biopharma, biotechnology, and medical device companies are focusing on next-generation clinical development, which has necessitated the convergence of science, data, and technology into unified solutions.
- Equitable development calls for the participation of a diverse patient population in clinical trials.
- Real-time monitoring and a risk-based quality approach ensure trial integrity, validity, and patient as well as site centricity.
- A robust clinical trial management system is needed to evolve quickly and flexibly to respond to future trends, streamline the trial process for subjects, patients, sponsors, and investigators, and improve trial outcomes.
- Our scalable, flexible clinical operations services meet customer objectives by integrating automation levers with deep clinical delivery experience to drive clinical project outcomes.
On this page
Overview
Focusing on new drug development, especially in unmet disease areas, demands innovative ways to bring safe and effective medicines to the market in the shortest possible time and reduce trial costs.
Challenges such as delays in study start-up timelines, inadequate subject recruitment and retention, lack of complete oversight on clinical trial progress, inconsistent data quality, increasing costs, lack of risk-based focus, and insufficient readiness for eTMF inspections contribute to delays in timely trial completion, thereby negatively impacting regulatory submissions.
Novel drug discovery approaches, including gene therapies, require collecting and analyzing data from genomics, proteomics, and biomarkers. The complexity in clinical trials is further magnified as data is gathered from diverse sources such as smart wearable devices, ePRO (electronic patient-reported outcomes), e-consent, tele visit, and direct-to-patient (DtP). Given the ever-evolving regulatory landscape, the industry is considering integrating this data into the existing study databases.
Clinical trial supply chain management needs technology to distribute medication seamlessly to investigator sites or patients. It also demands comprehensive human biological sample tracking, lab analysis, and safe bio disposal.
Innovative approaches are required to address these challenges and focus on data integrity, cycle time reduction, prompt risk identification, and timely interventions to ensure patient safety.
Solution
TCS provides a wide range of clinical operations support services across the entire study lifecycle with enhanced quality and efficiency.
Our services bring efficiencies to the clinical trial lifecycle through:
- Clinical study project planning and management support: Our clinical study project planning team creates and maintains the project plan, encompassing deliverables from study conceptualization through the submission of the final clinical study report (CSR). With our deep program and project planning expertise across various industries, our experienced clinical trial associates apply project management knowledge to large clinical trials, including multiple sites, countries, study phases, and therapeutic areas.
TCS ensures timely study resource allocation, monitors project risks, proposes risk mitigation plans, and tracks study budgets. We govern the progress from study start-up to study closeout, assuring our customers of complete supervision. - Clinical trial management systems (CTMS) support and end-to-end eTMF management: We provide end-to-end support across multiple clinical trial management systems with real-time updates and accurate data.
Our decades of experience in managing end-to-end eTMF have helped our customers focus on overall study timeliness, completeness, and quality, for an inspection-ready eTMF. Our knowledge of advanced industry platforms and strong technology levers has led to numerous transformative automations and innovations. - Centralized monitoring or risk-based monitoring (RBM) support: The industry is inclined to adopt innovative clinical trial data collection methods and monitor the study with a risk-based approach.
TCS offers centralized monitoring support using a risk-based quality monitoring (RBQM) framework and industry-leading tools. Our experts work closely with the customer in RBQM implementation programs, enabling the site monitoring team to focus on specifically targeted source data verification (SDV) and source data reviews (SDR) at the investigator site. TCS generates operational metrics, identifies proactive signals and data trends, and addresses data quality issues beforehand.
We share recommendations of relevant RBQM tools critical to quality (CTQ), ensuring the customer’s centralized monitoring team meets its objectives.
Benefits
TCS’ deep domain knowledge, ecosystem partnerships, and robust technology capability have helped our customers achieve upper-quartile performance (UQ) to reduce study cycle times.
We provide clinical operations support services in compliance with the International Council for Harmonization - Good Clinical Practices (ICH GCP) standards. Our focus is to continuously drive efficiencies, harmonize processes, and effectively implement evolving operational models.
TCS focuses heavily on quality data tracking in CTMS, ensuring better study governance and oversight for our customers. Our timely reports on study compliance, metrics, and open action item lists track the progress, improve overall study turnaround time, and ensure that customer study teams stay focused on strategic project milestones.
Using our data analytics and automation acumen, we have been able to reduce efforts, eliminate manual interventions, and optimize study costs for customers.
The TCS advantage
TCS is committed to providing best-in-class services, contextual knowledge, and point automation solutions.
Our domain consultants and technology experts are present globally and we offer customized solutions to meet your study-specific needs. TCS has delivered clinical operations services to biopharma and biotechnology companies for over 18 years.
Our subject matter experts ensure delivery excellence, optimize business processes, and adapt digitized tools to monitor performance, quality, and data compliance.
Our team is proficient in working on a gamut of tools across the landscape in CTMS, and project management tools, such as Planisware, and MS Project. Our eTMF team is well trained in all industry-leading eTMF systems such as Veeva eTMF and Documentum.
We periodically upskill our experienced clinical operations associates under the competency framework training program developed by our internal training academy, enabling the associates to stay tuned to changing regulations in clinical research.
TCS conducts metrics standardization and process benchmarking as per customer requirements to foster a culture of sharing lessons learned and continuous improvement.
Cases in point
Case in point 1: Customized clinical project planning support services for a global top UK-based biopharma
Discover how TCS’ clinical operations team facilitated improved project governance for the customer’s global project managers.
The customer’s clinical project management team faced challenges engaging with multiple stakeholders within the clinical study. This impacted the quality of project schedule, leading to study oversight issues.
TCS deployed experienced clinical project managers to participate in study team meetings. Our team developed and maintained a clinical trial project schedule throughout the study lifecycle. We also updated the study attributes in the customer’s resource planning tool, enabling accurate resource forecasting and planning for the study.
Our team also engaged in risk management discussions with respective stakeholders and updated the study risk mitigation plan at regular project review meetings.
With our efficient project management support, the customer’s global project managers were able to fetch timely and accurate study status reports, proactively manage risk alerts, and estimate resource requirements. Our efforts ensured better project governance by the customer’s global project managers, enabled compliance with the project budget, and met project objectives and timelines.
Case in point 2: Transforming eTMF management for a global top German biopharma
Learn how our team achieved all three key tenets of eTMF – completeness, quality, and timelines.
The customer’s eTMF team had a challenge working with multiple stakeholders—various domain leads and investigation sites across multiple geographies. Incomplete and inconsistent TMF documentation exposed clinical trials to potential risk of audit and inspection findings. The disjointed processes further impacted eTMF compliance.
Our project team provided complete eTMF management support throughout the study lifecycle, including TMF Planning, study start-up, conduct phase (collection and distribution of records to the site), document processing, secondary quality check, eTMF reports, eTMF dashboards, study closeout, and study archival support.
To ensure the health of eTMF and its inspection readiness, our team extracted and analyzed the reports, performed trend analysis, and followed up with the customer’s study leads and investigator sites.
Automating manual processes improved efficiencies in the eTMF process, leading to 98% quality, with 95% records filed within the prescribed timeline for each document category.
Case in point 3: Clinical operations process and role harmonization for a global Europe biopharmaceutical firm
Learn how TCS understands the customer’s business processes and offers customized solutions
The customer was looking to maintain data quality across multiple clinical trial systems. The lack of which impacted timely update of study milestones in CTMS, periodic eTMF health checks, and user access management across all these systems.
TCS stepped up to meet customer specific requirements and onboarded an experienced clinical study associate (CSA) team. The CSAs, being study-aligned, supported the global clinical operations team leads across the study lifecycle.
Our timely intervention ensured high quality data across multiple clinical trial systems, better study oversight, provisioned timely and reliable data in CTMS, tracked human biological samples, eventually assured inspection-ready eTMF for the assigned studies.
Our CSA team received accolades for the systematic approach, which helped adhere to compliance, improve accuracy in study data, and augment study governance. We now support more than 450 clinical studies for the European biopharma major.
