Clinical outsourcing is an effective and cost-efficient way to harness the resources and experts needed to carry out successful clinical trials and advance modern medicine and healthcare. According to The New Trends of Global Clinical Development Outsourcing Market report, data collected between 2015 and 2020 estimated CRO outsourcing would account for 72% of all clinical trials, suggesting that nearly three in every four clinical trials are run by a professional CRO partner.
You may already have a CRO that you are working with but feel that your relationship has changed over time and that they are no longer a good fit for your organisation.
When a CRO is missing deadlines, going out of scope or delivering poor quality work, the trust you once had can quickly diminish. Perhaps you feel like you’re no longer enough of a priority for your CRO, and your trial needs attention that it’s just not getting. Communication may have broken down, and the relationship isn’t working out as you hoped. Once the risks outweigh the benefits of a sponsor/CRO relationship, it may be time to engage a specialist CRO.
Things to consider when switching to a new CRO
We know that rescuing a trial nearly always comes at a critical moment in the study – often when tensions are high, and pressure is mounting. Choosing a CRO with proven success in study rescues can help to smooth the transition, particularly when it comes to ensuring fast, accurate transfer of data from one vendor to another midway through a project. You need a flexible, experienced team of experts who can expedite the transition of responsibilities, comprehensively audit the existing data and ensure ongoing data integrity – while also maintaining the level of attention and support that your study deserves.
Maintaining data integrity when choosing a new CRO
Data consistency is a key concern when switching data management, biostatistics and programming providers part way through a study. Transitioning data management activities requires careful planning and consideration, so it’s essential to have a knowledgeable and experienced data manager on board from the start, who can oversee the entire process.
The data manager and sponsor will need to decide how to handle the existing study database to ensure that the data is transferred smoothly. Some questions to consider during this transition period include:
- What database is being used, and who has the administrative rights to it?
- Should you keep the existing database, or transfer to a new one?
- Is there randomization, drug dispensation or other database modules that need to be transitioned?
- Are there any upcoming deadlines or review meetings that require urgent statistical analysis?
Whether you choose to leave the existing database with your original CRO to transfer it or build a new one, the process must be carefully mapped with a predefined plan to ensure the quality of the data remains consistent from start to finish.
We know that the idea of bringing a different CRO on board may seem counter-intuitive, but in fact, contracting with a specialist CRO is often just what you need to progress your study from ‘at-risk’ to back on-track. And when you work with a specialist provider with experience in rescuing clinical studies, the process can be smoother and more straightforward than you expect.
Is now the time to switch to a specialist CRO?
How do you know if you’re ready to switch to a specialist CRO? Here are some of the questions that you may want to ask when deciding if it’s time to switch your data management, biostatistics and programming provider.
- Do you have visibility into your clinical data?
- Are you continually receiving change orders from your CROs?
- Is your data management and biostatistics provider prioritizing your study?
- Does your vendor have robust systems and processes in place that enable them to respond quickly and proactively to mid-study updates?
- Do you have confidence that your data is being collected and analyzed properly?
- Is the vendor able to meet your timelines?
- Is the CRO team changing frequently, resulting in a constant state of transition that makes you concerned about the quality of your study and study results?
The longer you delay a switch, the more likely it is that your trial will lack the quality you need to produce reliable, accurate outcomes.
Why Veramed?
Veramed has a proven transition methodology that makes the switch simple.
Stage 1: Discovery
Comprehensive Gap review of work completed by previous vendor, including:
- SDTM specifications
- Statistical analysis plan
- TFL shells
This is used in proactive planning to enable us to ensure successful project delivery.
Stage 2: Definition and planning
- A deep-dive quality assurance report looking at the results of the latest internal and external audits
- 1:1 QA to QA video call to discuss key audit questions.
Veramed provides detailed and transparent pricing, with a budget summary provided in Excel to allow easy manipulation for internal budgeting purposes.
Stage 3: Launch and execution of the takeover
- Managed data transfer
- Determination of touch points and timelines
- Establishment of review cycles to obtain client feedback and ensure the project stays on track.
Read more about Veramed’s experience of transitioning Data Management, Biostatistics and Programming vendors.
Read more about Veramed’s experience of transitioning Data Management, Biostatistics and Programming vendors.
Are you ready to make the switch?
Navigating a vendor change partway through a clinical study is never easy, but by selecting a specialist CRO with extensive experience and expertise in study rescue, the process can be significantly streamlined while minimizing disruption to your study and ensuring data quality.
Find out more about selecting a specialist CRO over a full service CRO with our blog.
Success in clinical trials starts with preparation – but what happens when things go wrong?
Watch our webinar to discover actionable strategies to manage unexpected disruptions.
