Clinical trials can require data collection from many specialised and disparate sites and sources. Wipro Technologies highlights how its electronic solution has helped to manage a client’s process of data collection and trial management in a cost-effective and efficient way
The client had clinical trials that involved patients with thoracic cancer and that were running globally. Wishing to remain anonymous, this company was looking out for a more efficient way to get the trial data from the sites across the globe. Wipro was chosen as a partner to launch an electronic data capture (EDC) solution that would facilitate clinical data transfer across the globe from multiple sites, seamlessly.
The main objective was to enable the central data management team to collect data in a central repository, thereby enabling data managers to work in real time on clinical data and resolve any discrepancies. The ultimate benefit in doing this was to avoid delays in data collection and thus to reduce the cost of data collection and query management and to enable faster regulatory submission for the drug.
Wipro recommended an EDC solution to address this problem that involved implementing Oracle Clinical for data management, RDC for remote data capture and Thesaurus Management System (TMS) for Medra Codes and other medical coding standards. User-friendly interfaces were provided for the site personnel, study monitors and trial team, enabling easy data entry remotely from different sites across the world.
The use of paper case report forms (CRFs) for data capture was planned only if the site was not willing to participate in EDC. Online, easy discrepancy management and data validation without paper or manual processes were provided, along with automatic data extracts for analysis by statisticians.
The system was validated to comply with good clinical practice (GCP) regulation and FDA CFR Part 11 requirements.
implementation process
Wipro installed Oracle Clinical, RDC and TMS in different areas of the customer environment. Any gaps were identified through customer business process mapping. All the CRF pages (30 unique and around 112 standard pages) for the oncology Phase III clinical study were developed and the CRF design was validated against the GCP guidelines and Clinical Data Interchange Standards Consortium (CDISC) standards.
Training was provided for the users, including clinical research associates, data managers, study managers and IT teams based in multiple geographies. The solution supported the end-to-end user acceptance training and validation requirements remotely from offshore facilities in India. The post go-live support resolved any issues and changes that were requested by the customer. The RDC web link was also externalised for global usage.
With this implementation the customer was completely equipped with technology that can be scaled up for any number of EDC-based trials globally. The end-to-end implementation was completed in less than 13 weeks from the contract signature stage. The centralised database was able to manage study data from more than 12 countries with more than 39 sites. It also enabled them to drop sites and add new ones to speed up the recruitment process. This also provided a significant cost reduction and removed some of the geographical constraints of running this trial.
The complete packaged implementation services, with best practices built in, helped to gain the confidence within the user communities that an EDC system implementation could be carried out without too much interruption of their daily tasks.
In short, Wipro Rapid Trials platform unleashes the capacity to standardise electronic data management and data capture processes across the pharma, biotech and contract research organisations (CROs) that often span multiple geographies. This also allows drug manufacturers to use the CRO of their choice without having to compromise the data standards and data collection procedures.
The Rapid Trials platform aims to cut the total cost of ownership by 30–40% by way of sharing the resources across trials, while guaranteeing the highest data security possible, all without having to maintain in-house capital equipment and clinical operations and system support.
Wipro has six current pharmaceutical and CRO companies using this model in the Asia Pacific region, including a successfully delivered clinical data management solution for a complex multi-site, multi-country oncology trial for a biotech company based in Singapore.
Recently Wipro also went live with a study that is being conducted by a leading a UK-based CRO where Wipro went live in the record time of 10 weeks, which included platform set-up and study database design.
Wipro Rapid Trials platform built to improve data collection
Wipro Rapid Trials is a platform that is set up to accelerate drug development across the globe. Designed to improve data collection speed and data quality by creating a cost-effective and secure worldwide infrastructure (ISO 9001 and ISO27001 standards), it enables clients to conduct global trials without having to worry about IT infrastructure challenges.
The Rapid Trials platform is based on the Oracle Life Sciences software suite of products – an open standards-based platform for business process integration across the drug development life cycle. In this platform model Wipro provides business process outsourcing services, including clinical operations support and managed IT infrastructure, to allow clients to achieve their clinical research and development benchmarks much faster than the normal timelines.
