Warning signs and the way forward
No sponsor goes into a clinical trial with the expectation that their CRO of choice is going to let them down at a critical point, and that they may have to re-examine elements of the study or – in the worst case scenario – start again. But with so much penetration into the clinical process by CROs across the board (70 per cent of studies by 2020 according to some) it’s almost certain to happen at some point. When it does, you need to know that the company you turn to is equipped to analyse what’s gone wrong and then help you fix it. This is particularly true if the areas of concern are specialised ones, like biostatistics and programming.
There are many reasons why outsourcing can cause problems, and some are easier to identify than others. Maybe your CRO is unable to hit its milestones, or stick to the original budget, perhaps it’s unable to cope with the changing scope of the project, or the quality of its medical statistics is below what was promised. Alongside these are the ‘soft’ issues, such as the creeping erosion of trust, the answers to specific questions being frustratingly vague, until it starts to feel like they’re not just delivering less than they promised, but they’re below par as well as being unresponsive and disorganised.
When outsourcing has let you down once, it may seem counter-intuitive to turn to another CRO in order to get the project delivered, but when the part of the project that’s in crisis is very specific – for example, biostatistics and programming – approaching companies that have expertise in that specialised area offers the best chance of rescuing the study. And given that rescue is always required at a critical moment when tensions are likely to be at their highest, you need to be working alongside a company that has the right blend of PM skills and technical experience – because building trust where it’s been broken, setting realistic expectations of what’s achievable, and then standing by those to deliver results is just as important as being able to extract the right data out of another supplier’s badly documented – perhaps even broken – system.
When statistical reporting isn’t 100 per cent accurate, it takes a particular kind of CRO with a very specific mindset to step in and make such a “rescue” mid-stream to work, so it’s important to look for one:
- that’s innovative and open-minded.
- that knows the difference between a fast decision and the right decision.
- that understands process – ascertaining the project scope, sitting down with the sponsor as well as the supplier (if that’s possible) to identify where the study is stalled.
- that has a culture of getting things right first time (and the track record to back that up).
- that realises the importance of focus and clear-eyed thinking at the very time when it feels like the entire study reporting is in disarray.
- that can demonstrate deep technical knowledge of systems, the integrity of data and how they’re used together to meet regulatory requirements.
Bringing in a specialised CRO to perform a ‘rescue’ for study reporting need not be a disaster. With the right partner in place, you’ll have a good chance of turning the project round and still delivering it on time, as well forging a new and effective working relationship going forward. Take a look at the Case Studies below for some example scenarios.
Veramed Case Studies: Two examples of study reporting rescues
Scenario: Poor reporting practices from original supplier for a Phase III program, with a requirement for rapid response to regulatory requests.
Solution: Contractual agreement for provision of all original supplier code made available through installation of the full code library onto virtual servers to establish the integrity of the data reporting and programming code. Once integrity was established, Veramed were able to support all of the regulatory requests on behalf of sponsor.
Scenario: Conversion of raw data to SDTM format by current supplier to elongated timelines. Requirement to shorten conversion timelines to support critical path deliveries downstream.
Solution: Assess the feasibility of converting the existing data to SDTM and evaluating the likely impact on the timely delivery of the overall study reporting. Provision of detailed feasibility report detailed the risk-benefit of multiple scenarios, allowing the sponsor to make an informed decision on the best way forward.