CRO & Sponsor: Effective Relationships from the Start
posted: June 18, 2019
The work we do in the life sciences industry is vastly important. It’s not hyperbole to say that we are actually in the business of saving lives. Now, sometimes it seems like we are saving them incredibly slowly, since it can take a long time to get from clinical trials to a marketable product or treatment.
One way we can speed the process is by ensuring our partnerships and collaborations are effective from the start, so that the only things slowing down the process are actual changes to the clinical trial protocols themselves.
Successful Partnerships in Clinical Trials and Data Management
The clinical trial process, even for the smallest of startups, involves lots of people on different teams working separately, yet towards the same goal. You may even have a mix of internal and external teams. How can you ensure that these disparate groups, often separated by geographical distance as well as by area of expertise, are actually functioning smoothly?
There are several points in the process where you can actively improve your collaborative outcomes.
Clinical Trials are Costly
What are some of the costs involved?
- Site contracts;
- Clinical databases (e.g., EDC, IxRS);
- Site visits (site initiation, conduct, close-out);
- Vendors (e.g.,core labs, central readers);
- Patient recruitment;
- Sponsor salaries.
If you have a protocol amendment, you have to go through these costs again. In fact, it’s a given that you'll have protocol amendments, so you can double or triple these costs right up front.
Lengthy timelines add to the costs and the frustrations.
- 80% of clinical trials don’t start on time.
- Of that 80%, 20% have delays of six months or longer.
Additional difficulties include the of getting patients, and retaining them. Up to 30% drop out before a trial ends.
Choose the Right Partner
This sounds obvious, but making a conscious effort to choose the right partner from the outset can eliminate all kinds of problems, including helping with cost control. It will also make it easier to develop an effective working relationship.
Before you select a partner, there are some things to consider.
Your Culture & Structure: How will your culture match the one you are going to work with? Is your company new and small or mature and large? If you are a small, agile company and you partner with a bigger, more mature company you may find that you are dealing with a structure and rigidity that inhibits your flexibility.
Your Approach: Are you doing this by study or by program? We've seen organizations doing multiple studies at once, and working with different CROs. This can make it difficult to determine what's going on, who does what, and which roles apply in a given situation.
Internal Assessment: Look at what you already have available, consider your preferences and what is available. This is the time to look critically at the different clinical data management models.
Full Service CRO
Pros: Less hand-offs and less management. You can ask them to handle pretty much everything: “Can you please take care of my site management, data management, programming, and oh yeah, I also have safety, can you take care of that too?”
Cons: They tend to be generalists. They know the process at a high level. Functional expertise varies, and you may have someone who doesn’t understand exactly what you want them to do. Transparency can be more of an issue with a CRO. If you haven't carefully built communication into the process at the start you may find yourself wondering, "Just what is my CRO doing?" Reports and numbers might be more generalized.
So, thinking in terms of your study, is it something cookie-cutter or common? This is where the full-service CRO would make sense. Or do you have a complex study? If so, you'll want to consider using a different model.
Functional Service Provider (FSP)
Pros: Tend to specialize in one area. With this model, you contract some of your work to them and you have more control and oversight than with a full service provider.
Cons: Not hands-on, and if you have multiple FSPs, there is no one person seeing everything that is going on. One FSP group may be communicating to an internal group, while other FSP groups are not. You can short circuit this challenge as the sponsor by actively working to ensure communication is happening.
Pros: Full control.
Cons: Cost and scalability. It can be hard to put together an internal team. You might not want to do this on a first or even second phase one study, because you are likely assessing what's happening with your study, is the drug going to work, how's the safety profile, etc. It's also a major challenge to recruit the right people for your internal team and can take a lot longer than you want and be costly. You need to get your study started, not dedicate a lot of time to putting together the right team.
Pros: This model pulls a bit from each of the other models. You can have a CRO that does the work for you, and you can have an internal staff that provides oversight. You might even include an FSP, perhaps to help with some oversight support for the internal staff and to ensure that the data is being treated with care.
Cons: Active management; you've got to have someone strong, who is in-house that understands the process and the roles and is watching all the different pieces. Communication must be stellar, and it can be difficult to maintain transparency.
How Do You Find a Vendor?
Firstly, look at the vendors you already have relationships with. If there is no current vendor that can perform the work, consider vendors you’ve used in the past. If that doesn’t work, start asking for recommendations and referrals from people you know and trust. As a last resort, you can find someone completely “cold” via search.
Selecting the Right Vendor – The Process
What do you need to think about when you are starting the process of selecting your vendor?
From the very start of the process, when you send out a Request for Information or a Request for Proposal, focus on your business need. Don’t consider your budget now.
It’s important to allow plenty of time to do a bid defense. Don’t give the bidding company just 30 minutes to come in and pitch when you will be working with your chosen vendor for 2 years or more. Give yourself plenty of time to learn about each potential vendor.
Use scorecards carefully, only grading what is really important to you/your organization. Discuss and agree on what these are ahead of time.
When you are getting close to a decision, start thinking seriously about your contract. Bring in your legal team or your legal resource early, so that they are familiar with what is going on. If audits need to be done get them scheduled now. We've all experienced receiving the protocol and being expected to run with it -- immediately! You don't want to get stuck in the contract cycle at the very last second.
3 Keys to Successful Partnerships
Having chosen a vendor your work is really just beginning. Now you have to work with them to ensure a successful partnership and the best possible trial outcomes. Successful partnerships don't happen by accident. There are three main components to making your vendor relationship work: communication, trust and respect, and teamwork. All three stand alone, but are also interconnected and build on each other.
Start with a well-planned kick-off meeting to get everyone on the same page and in the same boat.
- Review scope of work and make sure everyone understands. I’m sure that you, like me, have been in organizations where the contract requirements were not understood by one group or another, and that can lead to distrust right out of the gate.
- Discuss communication and escalation paths: who do you talk to when things go bad?
- Establish deliverables, including reporting and metrics.
- Define timelines.
- Risk and risk mitigation.
- Establish a RACI.
- Calendar meetings: Will they be weekly? Monthly? Decide now and get them onto everyone's calendar.
- Whose SOPs will you follow? Make this clear from the start.
To maintain the relationship, maintain the communication you started out with
- Assume nothing: Make a point of this from the start to avoid all kinds of conflict.
- Stay engaged: Keep the team engaged.
- Treat a new vendor like a new employee: Spend some time with them, don't just send them off with the protocol.
- Meetings: will they be face-to-face, teleconferences, or a mixture?
- Study plans: These are living documents. Refer to them often, and update as needed.
- Address concerns immediately: This can't be stressed enough. Handling concerns in a timely manner builds goodwill and trust and keeps the study moving smoothly.
- Take time to understand the data: We've seen organizations create huge binders full of reports, but then no one refers to them.
- What is the purpose of the metrics: Quality? Operational?
- Good metrics are actionable. What can we/should we do with this? Identify training or process needs. Also tells you what has not occurred.
- Track trends; it helps you discover things that need to be changed.
- Track changes over time.
Trust is built one day and one interaction at a time and yet it can be lost in a moment because of one poor decision. Make the right decision.
- Safe environment: When your people feel safe they will tell you what is going on and ask for help. Without a sense of safety, they may pretend. They will tell you to your face that they understand, and that everything is fine. Then they'll ask a colleague or search Google to find out what it is they need to know.
- Clear expectations: If people don't know what's expected of them, they can't get the job done.
- Responsive: Both the sponsor and the CRO need to respond. Even if it's just, "Hey, I got your message and I'm working on it," this level of responsiveness tells people that you care and that they can trust you.
- Be reasonable: No trial is perfect, things will always go wrong. Keep the issues in perspective.
- Care about each other’s success: This may sound obvious, but it isn't always automatic.
If you don't have trust, you'll get unhelpful, one-syllable answers to your questions: "Are you doing reconciliation?" "Yup."
That's not very useful, and will just add stress to your trial. When there is a high level of trust your CRO will likely let you know what's going on before you even have to ask.
Much of this is related to trust, and can flow naturally when you’ve built a foundation of trust.
- Shared common goals: You know what you are working towards, and you are all in it together.
- Defined accountability and responsibility: everyone knows what they are responsible for.
- Comfortable exposing weakness, failures, and fears: People often feel like asking for help or admitting they don't know something is a sign of weakness, but when there is trust and solid teamwork it becomes okay to not know something and ask for other's input. This promotos better teamwork.
Barriers to Successful Relationships
Looking at the CRO / Sponsor relationship from the other side, what gets in the way of a successful partnership?
Expecting Perfection: Have a plan, but be flexible and go with the flow. “Plan A” never survives. “Plan B” rarely survives. New information comes in and you have to adjust. Team members will stumble, mistakes will happen. Address it, chalk it up as a learning experience, and move on.
Lack of Participation: Everyone has to participate or results will suffer and others will get frustrated. Encourage unfiltered dialogue on issues (no politics or ego). Remember, our purpose is saving lives.
Loss of Teamwork: Many things, including the above lack of participation, can lead to the teamwork falling apart. Some more significant issues include:
- Egos get in the way. - personal Personal goals are more important than team goals.
- Lousy communication and not telling people what they need to do.
- Poor leadership, lack of appreciation.
- Implementing a plan that you know isn’t going to work.
- Personal stubbornness. You know this person, who just digs their heels in and refuses to do something for no apparent reason.
Following the tips and guidelines above can help prevent these barriers from forming in the first place.
Happy Team Members Make Effective, Productive Teams
None of this is rocket science, but it can seem like a lot of work that is unrelated to your “real” work. Just a little extra effort can keep your clinical trial on track, keep your data clean, and can reduce your expenses.
People find fulfillment in their work when there is a sense of connection and belonging. Employees who feel their work matters are more engaged and effective.