The Sponsor CRO relationship is a hot topic within many Sponsor Clinical Operations teams. Unfortunately, not all feedback is positive.
As financing opportunities increase, biotech start-ups have mushroomed. Since most of these companies start with lean in-house teams, they look to Contract Research Organizations (CROs) for the additional manpower needed to run trials. It’s common for small companies to outsource not just study management and site monitoring, but also data management, medical monitoring, region/site selection, and regulatory functions.
Even larger companies have jumped on the trend. Clinical trials require the most work during start-up and close-out, so CROs have become a more flexible source of manpower than in-house staff.
Since more trials are outsourced, with CROs playing an intimate role in them, bucking the norm and fostering a positive and productive Sponsor CRO relationship is crucial. The key is fully integrating them into your team.
Pick the right CRO!
Ensuring a great Sponsor CRO relationship starts even before you select a CRO. CROs differ via:
Cost – Self-explanatory. Sometimes a low upfront fee may cost you later.
Example: changing CROs mid-study due to non-performance or paying repeatedly for out-of-scopes or change orders due to line item inflexibility.
Manpower – Some boutique CROs may not have the personnel you need to run your huge Phase 3 trials
Region Specialization – You may want to use a regional/country-specific CRO if most site staff don’t speak English or there are cultural or regulatory nuances. Example: Japan.
Therapeutic Area Specialization – You may want to use a boutique CRO specializing in rare diseases if your company doesn’t have existing relationships with these sites. You may also wish to seek help regarding study design or subject recruitment in a specific TA.
Processes and Systems (CTMS, e-TMF) – Some CROs have extensive processes and systems that you don’t and may want to take advantage of. Others may rely on Excel Trackers and your SOPs. The former may cost more.
Culture – This is hard to define but captures everything from the CRO considering anything not tightly defined by a line item as “out of scope” to staff turnover. Ask industry colleagues for their feedback on various CROs.
Account for all these when choosing a CRO and don’t expect miracles. That low cost CRO may look good now, but will cost your sanity when you realize they’re literally not staffed to complete your tasks and run your huge trial.
Align on expectations before study conduct
Avoid surprises, misunderstandings, and bad feelings by establishing:
Whose SOPs you’ll be using – yours or the CRO’s. If both, explicitly document which of each.
Plans/procedures and who should draft each.
How ad-hoc request for custom reports, processes, or resources will be handled. Will the CRO accommodate these or consider them out-of-scope?
Whose systems will be the “source of truth” for study tracking and metrics (see “Study Management Tools” section below).
Trust and don’t micromanage
CROs can take a load off a Sponsor study team’s shoulders by divvying up tasks. This allows in-house ClinOps roles to be more management-oriented and strategic, at least theoretically.
However, per GCP guidelines, Sponsors have ultimate responsibility for trial conduct despite this outsourcing.
So how do you strike this balance between efficiency and responsibility?
Bake CRO authority into study plans/processes. Give them enough leeway so that only large outliers are escalated to you.
Example: For budget negotiation, define a cap under which the CRO can automatically approve the budget. If site goes over the cap, give CRO instructions to do the initial back-and-forth.
Example: For Site ICF review, define basic changes that can be automatically approved. Also ask your CRO to keep a running list of preceding changes that were approved by you so that they can automatically approve these without your consultation.
Only spot check their work:
Example: Review the first 3 monitoring reports for each CRO CRA.
Example: Review the first 3 IP release forms and packets from each country.
For larger tasks, review the end deliverable:
Example: If you assign your CRO to create a study newsletter or Safety Management Plan, ask them to create the first version.
If you end up doing the heavy lifting for a task, you’re not getting the full value of the line item. Even if the CRO is way off the mark with the first version, it’s worth following up with an in-depth call to re-state expectations. The more you do this, the more your CRO will acclimate to your style and expectations.
Be 100% transparent and aligned during study conduct
Your in-house and CRO teams should make a united front when dealing with sites or even upper management.
But too frequently, Sponsors take an “us vs them” attitude towards their CRO. This silos the sites’ interaction with the Sponsor and leaves them open to variable communication.
Share as much information as possible with your CRO, even sensitive/negative. Let’s take for example the possibility of there being an IP shipment hold due to unforeseen shortages, and you don’t want your sites to know quite yet. The inclination is to withhold this same info from your CRO. However, it’s your CRO who must field questions from a site about why they can’t receive extra IP shipments for a particular subject. If your CRO knew the full picture, they could more knowledgeably act. And instead of managing two sensitive situations, you can focus on managing one.
Motivate and reward
Your CRO counterparts are teammates, so treat them like your own. Your counterparts are also human and would like to know the “why” behind their work. Sometimes, CRO personnel will be assigned to several Sponsors. Who do you think they’ll allocate most time to? The Sponsor who acts distant and merely assigns work? Or the Sponsor who engages them fully? This is crucial for the Sponsor CRO Relationship.
Praise generously. Say “thanks” liberally. If they go above and beyond, email them and cc their manager.
On the other hand, critique helpfully and thoroughly. Re-train them in detail if needed. Then trust that they’ll improve. Don’t just continue an endless loop of berating and venting. If things don’t get better, it’s best to request a personnel change (see below).
Share victories. If a study milestone or other win is achieved, let them know. Better yet – thank them and call out involved individuals by name.
Share data (if your company policy allows). Everyone likes to see study progress and “behind the scenes” info.
Explain the rationale behind your strategies and directives to them. They’ll love understanding the bigger picture behind their work. Contextualizing their work also empowers them to make correct decisions, which in turn, help them run the study better!
Cut losses early
Within the same CRO, there can be quality differences between individuals and even entire teams.
Sometimes after a CRO individual joins your team, their lack of fit within the project or in-house team (aptitude or personality-wise) surfaces quickly. If you notice this, request a personnel swap and be very clear about what qualifies the next candidate must have. The sooner you do this, the less hassle (training, transition plan-wise) everyone has.
Use the same workflows and analytics
It’s best to have a single “source of truth” (SST) that you and your CRO can draw from. For example, you should have an SST for critical study areas such as subject screening/enrollment, site activation, monitoring report review, etc.
Perhaps you use your CRO’s CTMS for essential study information and supplement with Excel trackers. Perhaps you both use multiple Excel trackers. Or, perhaps you use a complete solution such as ClinOps Pro.
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Usually, when a CRO maintains a CTMS, they’ll provide you with its reports. Because the CTMS configuration/report wasn’t defined by you, you may end up creating an Excel tracker that’s more custom to your needs. You’ll need to then manually enter CTMS info from it.
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When there’s no CTMS, everything is tracked from separate Excel trackers. These are usually emailed back-and-forth, or saved in the Sponsor’s doc repository, which is then shared with the CRO.
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You could also use the ClinOps Pro and do away with Excel tracking altogether.
As you see, standard methods encourage shadow tracking and redundant work!
Regardless of your approach, it’s important to establish:
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Which tools will be used
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For what purpose will each be used
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With whom will each shared
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How will each be shared
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How frequently will each be shared
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Who will update these
