Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
Outsourcing PV: Keys for a Successful Partnership
Posted on January 25th, 2017 by J.-P. Clement MD in Pharmacovigilance
This is the last of the blog series on outsourcing PV activities. At this stage, you have identified what PV activities to outsource, the due diligence is complete and the best vendor is identified. The contract is finally executed and you are ready to go. Congratulations! The preparation part is done and you are ready to harvest the benefits of this new collaboration. There are still a few points to consider if you want to reap the maximum impact and benefits from the collaboration.
Develop trust and be patient
The collaboration you have established is there for the long term. There will be a learning curve for both partners to settle into the new activities, which implies behavioral changes and switch of role from a doer to the one overseeing tasks for you. It is never easy to adjust to a new distribution of roles and responsibilities. Managing this relationship as if the vendor team was part of your own team will help. There is always a mentoring/training phase when your internal team is growing and there is not much difference here. There will be a lot of details to iron out during the first months. Patience and perseverance pay.
Be open and transparent, communicate clearly your expectations, hold all parties accountable:
Even if the respective roles and responsibilities are clearly defined, there will be challenges and potential issues down the road. The ability to clearly and constructively voice any concern will help foster a culture of trust and collaboration. Efforts to understand the vendor’s point of view will facilitate issues resolution. Regular discussions with the operational team and their leaders will create connections and confidence. Restating regularly to the internal or the outsourced team what are the expectations for this new collaboration will ensure adherence to common vision and objectives.
Process improvement and performance dashboard:
Any process can always be improved. As both parties want this alliance to be successful, continuously looking at opportunities to do better and match the expectations is important. Compliance to agreed-upon performance metrics is essential, both in terms of timelines for processing and quality of work. How can we do better is a question that should be asked again and again.
Exert the right level of oversight and respect the established delegation of responsibilities:
Do not mistake overseeing activities with completing actual operational tasks. You are here to guide and train as needed, until the job is done right. You should never be in a situation where some of the vendor’s work must be redone by your team, if expectations are clear and issues discussed upfront. This will eliminate confusion and ensure that you are cost and resources effective. Otherwise you will reach an absurd situation where you pay a vendor to do a job you will end doing yourself.
Communicating issues through email is a treacherous path. It usually adds misunderstandings, which create unnecessary complexity and sometimes frustration. In case of problem, discuss live, if time allows. It is important that some of the vendor’s team is in the same time zone as yours, so there is a constant and open connection with the outsourced team. Always prefer transparent and honest discussions with minimized emotions and maximum focus on solutions. Do not judge, focus on problems and issue resolution.
Celebrate success but prepare for the rainy days:
Encouragement and positive messages are great to maximize a team’s engagement and productivity. Recognition of strengths and weaknesses should apply equally to the vendor’s and the company’s PV teams. Rarely, the partnership will go south, looking beyond any opportunity to repair. If you keep track and document the issues discussed and the lack of significant progress, you may be able to escalate for a last chance remediation, or to support the decision to switch to another partner – which will always be painful and costly.
The management of a partnership with a PV vendor is not radically different than managing a team through Human Resources and Leadership approach. To successfully lead a team, you should be a good mentor, define clearly your expectations and hold others accountable. You should be transparent in your actions and intent, and be open to dialogue. Regular performance discussions should take place, focusing both on strengths and on areas of improvement, with measurable action items and development plans. Keeping this analogy in mind will help you partnering for the long term with great benefits. Make it work!
Download our free whitepaper entitled “Identifying Plausible Adverse Drug Reactions”
R&D Solutions for Pharma & Life SciencesWe're happy to discuss your needs and show you how Elsevier's Solution can help.
J.-P. Clement MD
Executive Pharmacovigilance Consulting
- The Liabilities of Pharmacovigilance Activities
- What Are Best Practices in Literature Monitoring for Top-performing Pharma Companies?
- FDA Regulations Reform? Risks and Benefit for the Approval Process of New Drugs
- The Four Cornerstones of a Pharmacovigilance Organization
- The Change Imperative: Finding the right balance as times change