Introducing Kalyan Obalampalli: A Leader in Clinical Trial Vendor Selection and Management
Kalyan Obalampalli brings over 20 years of experience in clinical operations to his role as Chairperson at the upcoming COG West Coast conference. As founder of ClinAI, Kalyan now helps biotech companies optimize their partnerships with contract research organizations (CROs) and vendors. I had the pleasure of interviewing Kalyan to gain insights into his expertise.
When asked what main factors he considers when selecting a CRO, Kalyan responded:
"Having assisted Biotech companies in vendor selection through ClinAI for over three years, my CRO selection process centers around four critical factors: cultural alignment, experience, a collaborative partnership approach, and a dedication to technological innovation. Let me elaborate on what each entails:
Cultural alignment is critical when selecting a CRO. Once a study starts, challenges and changes are inevitable. At that point, a transactional approach won\'t suffice; it has to be a true partnership. A strong cultural fit also ensures effective communication and collaboration.
Experience and Expertise: Sponsors often ask how many studies a CRO may have completed in a specific T. But it's not about the number of trials completed, it is about the project team's experience in that specific therapeutic area that matters. Expertise tailored to the study's focus is invaluable especially in rare disease.
Cost-effectiveness: Striking the right balance between cost and quality is essential. The cheapest option may not be the best, but it's vital to find a CRO willing to negotiate and share risks, especially in this environment when funding hasn't been easy.
Technology: Timely information sharing is critical to avoid surprises. A CRO's technological capabilities, such as platforms that provide real-time updates on progress, risks, and milestones, are indispensable."
On the biggest challenges when initially engaging CROs, Kalyan shared:
"You've touched upon a topic that often goes unnoticed -- the onboarding of new vendors. While many focus on the CRO's performance, I would challenge sponsors with a different perspective: how you can facilitate the assimilation of the CRO into your team and ensure seamless collaboration?
One of the biggest challenges lies in personnel dynamics. Ensuring that the vendor is onboarded effectively, organizing a face-to-face kick-off meeting, and aligning on quick wins that can invigorate and motivate the team from the start are crucial steps that go a long way in fostering a successful partnership.
In essence, the initial stages of engagement with a CRO are critical for setting the tone of collaboration. It's about working together as a unified team, sharing common objectives, and proactively addressing potential challenges."
On reviewing CRO progress and performance, Kalyan emphasized:
"I am going to keep this really simple. There are four key areas of vendor management and if done correctly, you will ensure that your studies never go off track. They are 1) Time 2) Money 3) Quality 4) Relationships. By carefully selecting the right Key Performance Indicators (KPIs) through in-depth team discussions and implementing a robust tracking system, you can effectively ensure that your studies remain on course."
When asked about "red flags" with CROs, Kalyan advised:
"CROs where you don't see the BD person once the deal is closed, CROs that don't want to commit to timelines and milestones, who don't want to share the risks of non-performance, who are not responsive to requests are probably not the best to work with.
I would say focus on CRO selection and weed out CROs who don't want to commit to (for e.g.) enrollment projections (with the understanding that things can change), who don't want to follow the templates provided by Sponsors to provide their proposals, who don't bring the Project Manager (who will be working on the project) to the bid defense meetings, who do not commit to put in writing what's being verbally agreed upon... these are all red flags. I would urge you not to wait until the vendor is selected, instead vet them well and select the best possible fit to start with.
Once you select a vendor you lose most leverage. So, start early, pick the right vendors and chances are your life will be much easier."
Finally, on advice for establishing strong CRO partnerships, Kalyan recommended:
"No two companies are the same but as a general rule, if you want to find the right CRO, start early, I cant stress this enough.
Secondly, know what you want. Provide a meaningful Request For proposal that clearly delineates what you want based on your study so that the vendors can get back with a meaningful proposal.
Thirdly, ask the right questions. You can't blame someone for doing something that you didn't say they could do. Also, don't assume. When in doubt, ask and confirm.
Finally, these contracts are worth tens of millions, don't make a decision based on someone's prior experience, or because a friend recommended them to you or you had a good chat with the BD person at a conference. Have a data driven approach.
Compare vendors 1:1, not just budgets but quality, commitment, ability to collaborate, share risk, etc. Capture the quality of responses to your questions quantitatively. Negotiate... I see many times negotiation is not small biotechs' forte. Finally, select a CRO through a documented democratic process involving key stakeholders.
Once you select CROs, know that they are the Doers. Consider them your partners and ensure that you share your plans with them, seek mutual wins, solve problems together when there are challenges and do the simple things like paying on time correctly. It's crucial to establish a feedback mechanism that allows you to provide input on areas that need improvement. Vendors value feedback from sponsors as it enables them to address issues promptly and prevent them from escalating."
Kalyan's decades of experience enabling successful clinical trials, along with his new ventures in vendor optimization, make him a leader in the field. We look forward to learning more from Kalyan at the upcoming COG West Coast meeting.