Ensure negotiation power to leverage success

In a small and virtual biotech company a major concern is the risk of operational failure of your only one or two projects.

Failure could be defined as substantial delays, considerable increase in cost, jeopardized data quality and integrity etc.

The environment you have to maneuver in is marked by a high degree of pressure on timelines, cost, high need for value generation and decision makers with very little hands-on Clinical Research Management experience.

On top of this, you may quite frequently also face the need to invest significant developmental effort into your project, since you may work in an orphan disease area with only limited or no previous experience with industry sponsored drug development projects amongst investigators/CRO's, no well-established primary endpoints, no well-established conventions for relevant trial designs etc. This further increases the level of uncertainty of your project assumptions - and can only be addressed to a limited degree throughout the planning and start-up phase.

As the leader of this process you must keep focusing on how to secure power to impact, change and adapt  at any time point and any aspect of the process and the ability to react to as many unexpected events as possible.

The key question is: "How to secure sufficient leverage and negotiation power in the collaboration with your vendors?"

First of all, disregard the viewpoint "Our company is a small player and therefore we will never be able to obtain the necessary impact, attention, negotiation power"..... Then you are setting yourself up for failure.

By focusing on the following elements you can keep enormous amount of power - even as a small player:

• Acknowledge the fact that clinical projects are complex, filled with uncertainty, based on assumptions - and are fully dependent on people with different competencies, experiences and personal agendas. Make this the key focus point when you define your project and outsourcing strategy.
• Build expertise in-house - and use your knowledge to define and lead the work that needs to be carried out
• Be very detailed in your contract specifications. The more detailed - the more negotiation power
• Consider a team-integration approach - only outsource true operational aspects - and keep all coordination, strategic and leadership aspects in-house
• Do not be tempted by the notion that project management is purely operational and has no strategic elements
• Create a vendor selection strategy before you initiate your vendor selection process
• Perform diligent vendor identification and selection exercises
• Embrace the fact that vendors have other agendas then you - and ensure to create win-win solutions in your negotiations
• Create competitive vendor selection and contract negotiation processes, hereby keeping negotiation power to the very end ("competitive vendor negotiation" means negotiating with several vendors in parallel)
• Do not sign a "Letter of Intent" - negotiate your contracts to the end before kicking-off your project
• Create milestones based on underlying vendor processes 
• Ensure a way out in your contracts
• Be genuinely prepared to terminate contracts - and build your team and strategy in a way that gives you the power to do so

As you can tell from the above - the cornerstone of a successful clinical project is defined during the planning and start-up phase - prioritize it - do not rush it!