Key Takeaways from Outsourcing in Clinical Trials
Contract Research Organization, Clinovo tells us about their experience and takeaways from Outsourcing in Clinical Trials Southern California.
“My colleague Joshua (Associate, Business Development) and I attended the Outsourcing in Clinical Trials (OCT) Conference in San Diego on September 24th and 25th, 2013. I have to say, the events put up by the Arena group are extremely valuable and the speakers are of excellent quality. These events are of particular interest to Clinovo, as they address the best practices for successful Sponsor/Contract Research Organization (CRO) collaboration. I don’t think anything I heard was new or revolutionary, as I believe that at Clinovo we always strive to follow the principles the speakers outlined, but it never hurts to reiterate them.
Here are some of my key take-aways:
- Set up expectations that are mutually agreed upon by both parties: It is important to define expectations that both parties understand and agree on in order to avoid bad surprises down the road. I would add to this: define clear responsibilities. Your CRO needs to follow through and be held accountable for what they are responsible for.
- As a Contract Research Organization (CRO), never promise what you can’t deliver. At Clinovo, we consider this a principle of particular importance. A successful relationship relies on trust, and that implies complete transparency on what one can deliver in what timeline. Before we give our milestone-based plan to our clients, we always check internally that the team is able to deliver what is outlined in the plan, and on time. Additionally when a problem arises, a CRO must be transparent with the sponsor and discuss the issue with a proposed resolution.
- Include all vendors at the kick off meeting. I had never thought about inviting all vendors to our kick off meetings, but it makes complete sense. Vendors are in pursuit of the same end-goal; delivering the highest quality to their customers, and contributing to bringing medical innovations faster to patients. Therefore, getting to know your counterparts and aligning goals is instrumental for a fruitful collaboration.
- Plan the unexpected. You should always prepare a mitigation/risk plan. What happens if enrollment doesn’t start on time? Plans need to take into account what to do if things go wrong, and be detailed enough for anybody to take over if necessary.
- Choose a CRO that is truly integrated to your team. Sponsors and CROs need to practice cooperative, strategic planning. As we all know, 1+1=3. Vendors are in the same boat as their clients, and will only deliver higher quality by truly understanding in depth their customers’ needs, processes, and values. Being fully integrated is key to a successful clinical trial.
I also wanted to share a great talk from SynteractHCR on how to select your optimum Electronic Data Capture (EDC) system. Below are 7 insightful recommendations:
- Develop high level requirements with all stakeholders – It’s hard to get everybody’s input, but try.
- Separate your requirements into must-have and nice-to-have.
- Avoid subjective requirements (e.g. nice GUI): It has to be something that is quantifiable that you can test.
- Determine which companies are likely to invest more in development and expend their EDC solutions.
- Look at your vendor’s system roadmap.
- Understand how the EDC system can integrate with other systems.
- Check reference accounts.
I want to add that, in the end, it all depends on your internal needs. There is no one magic solution or system out there that works for all sponsors. There are many considerations to take into account when choosing an EDC, including budget, resource capacity, the complexity and length of the clinical trial. So at the end of the day, it’s all about how your vendor integrates to your team and how your system is suited to your requirements.
Director of Operations, Clinovo”
- See more at: http://blog.clinovo.com/key-takeaways-from-outsourcing-in-clinical-trials-conference/?goback=%2Egde_5089036_member_5793132385511956480#%21