Medidata and PROMETRIKA co-authored this blog. PROMETRIKA is a global, full-service contract research organization (CRO) supporting the biopharmaceutical and medical device industries. PROMETRIKA has been a Medidata CRO partner for 11 years and is accredited in Rave EDC, Coder, RTSM, TSDV, and eCOA.
Clinical trials are rapidly evolving and becoming more complex as they continue to adopt novel technologies and approaches. Factors such as the number of sites and countries involved, study phase, indication, design, procedures, and the number of data sources and data points collected contribute to this complexity, imposing a strain on study execution. Furthermore, in recent years, the biopharmaceutical industry has witnessed changes in business practices and an increase in merger and acquisition activity.
In this highly dynamic environment, it is not surprising that we have observed a notable uptick in requests from new and existing clients for rescues of a clinical database. Even with careful planning, many factors can present unforeseen challenges or setbacks that can put research programs at risk. Our ability to successfully rescue studies offers a lifeline to concerned clients.
While there are a variety of study components that may need to be rescued and transitioned to another vendor (e.g., administration, clinical operations, project management, technology), in this post we focus on the rescue of clinical trial data and provide a five-phase approach to maximize the chances of success. By understanding the key elements of a well-executed rescue plan, sponsors and CROs (contract research organizations) can successfully navigate the expected challenges.
Why Are Rescue Studies Necessary?
Drawing from our experience, rescue studies are typically requested in the following situations:
- Acquisition: When a study is transferred to a CRO or acquired by another sponsor company, the clinical trial data may need to be migrated to a new database, EDC system, or platform.
- Strained sponsor–CRO relationship: The relationship between the study sponsor and the original CRO may become strained.
- Failing to meet expected outcomes: When a study falls short of its anticipated outcomes, tested rescue techniques can improve the chances of success.
Study rescues often require the transfer of clinical trial databases and a seamless transition of data. For instance, PROMETRIKA is often called upon to transfer a study from one URL to another. Study rescues often involve a significant investment in financial and personnel resources. However, transfer of database ownership is often a more cost-effective and time-efficient approach than either initiating an entirely new study or staying the course. By intervening and implementing necessary corrective measures, a study rescue can help mitigate risks and address critical issues so the study can proceed toward completion, benefiting all stakeholders.
Common Challenges Associated with Study Transfers
Transferring a study database poses several challenges. Sponsors typically have valid concerns regarding the feasibility, duration, and impact of the transfer of database ownership on study downtime, site operations, and data integrity.
Although each transfer is unique, the duration generally depends on the study’s stage and volume of production data. If the study is still in the development phase, the transfer is typically straightforward and fairly quick, with the primary focus on rebuilding integrations on the new URL and an overall review of the CRF and EDC design. Conversely, the duration and downtime for a study in production depend largely on the volume of production data. The more extensive the data, the longer both will be.
Key factors determining a successful study transfer are effective communication and close collaboration among stakeholders, including the sponsor, exiting CRO, new CRO, technology platform providers, and any third-party vendors. Each member of the team plays an important role:
- Sponsor: Communicates the rescue’s intent and facilitates collecting necessary documentation.
- Exiting CRO: Provides essential documentation, maintains site communication, provides access to data, and establishes data quality expectations with sites and clinical research associates.
- New CRO: Oversees the process to ensure smooth coordination, generates timelines, and serves as the main point of contact for issue escalation. Data managers and database programmers analyze, plan, execute, and verify the process, ensuring data integrity.
- Technology Platform Providers: Integrate systems, handle URL provisioning, ensure the availability of required modules, and facilitate loading medical dictionaries.
- Third-party Vendors: Consider impact to existing procedures and data flow, such as clinical supply acquisition or laboratory data transfers
PROMETRIKA and Medidata have participated in rescue operations under many different circumstances over the years, and the most efficient ones have relied on a unified, cloud-based platform, such as the Medidata Platform. Platform solutions offer centralized data management, data migration tools, and seamless integrations that enhance data quality and facilitate real-time stakeholder communication and collaboration to streamline the process and minimize study downtime.
“Transferring databases and data management responsibilities from one entity to another may be a daunting prospect unless it is handled by experienced teams using world-class technology. The PROMETRIKA-Medidata team has a proven record of success in such rescue studies.”
Miganush Stepanians, PhD President & CEO
Five-Phase Process for Successful Study Transfers
PROMETRIKA has developed a comprehensive five-phase process to ensure the best chances for a successful study transfer. These phases encompass technical and data-related aspects, with each phase building upon the previous to create a seamless progression.
These phases are:
- Analyze: This phase involves technical and data analyses that proceed in parallel. A thorough examination of study documents determines the technical requirements, such as medical coding, local laboratory configuration, and integrations (e.g., RTSM/IRT, eCOA). The data analysis provides insight into the volume of existing subject/form/query data and forms/casebooks that are SDVed (source data verified)/reviewed/signed.
- Plan: This is the most important phase, where the technical and data rescue needs are carefully mapped out. This includes determining the best approach for data rescue, such as re-entry or batch upload, and developing detailed plans for configuration, user acceptance testing (UAT), and data handling. Technical and data planning are done in parallel.
- Execute: The execution phase puts the plans into action, starting with the Configuration Plan, followed by UAT, and then the Data Plan.
- Verify: This ongoing process ensures each step of the transfer is executed as intended and produces the expected results. It goes hand in hand with the execution phase.
- Activate: In the final phase, the rescued study goes live on the new URL, and comprehensive documentation is compiled to document the entire transfer process. The original study or URL is decommissioned, completing the transfer.
Although the decision to rescue a study may seem daunting, rest assured that it can be accomplished confidently by adhering to a proven process of careful planning, effective communication, and seamless execution. Moreover, a unified platform can significantly enhance the process. Unified platforms provide a streamlined and integrated environment that facilitates the seamless transfer of data and enables effective communication among all rescue study stakeholders. Leveraging the right process, experienced partners and a unified platform can make rescuing a study and executing a clinical trial database transfer an efficient and achievable milestone leading to reaching study goals and objectives.