LEGAL SERVICES

Contracts Associates attorneys can help you manage risk and accelerate your contracts in a variety of ways. We can fill in gaps by augmenting your existing legal team or we can serve as in-house counsel.
 

Managing Risk

 
As true team members, we can help your organization manage risks though counseling, training and demonstrating for your teams, the practical application of corporate policies and procedures to business operations.
 

Implementing a Contract Management Strategy

 
Our attorneys can formulate a global contracting strategy that ensures compliance with the FCPA, the PhRMA code, FDA, HHS and OIG guidance and the Affordable Care Act, among other applicable laws and guidance. In particular, we can help you delineate a policy for making payments to ex-US clinical sites and vendors in order to prevent the same questions having to be addressed, mid-study, for every contract in Hungary, Poland, Mexico, Russia and the like. A solid action plan, clearly communicated to one’s CRO and clinical team, can prevent months of emails and conference calls and accelerate finalization of your study agreements.
 

Formulation and Coordination of Responses to Due Diligence Requests

 
We can formulate a contract management strategy that includes: a central location for a list of all company contracts, a contract template library with consistent and favorable terms across all agreements, and a set of contract “fall-backs” that serve the same ultimate goal: material contracts with terms your potential partners and/or investors want to see. Whatever strategy we ultimately implement at your company will be helpful to FDA and other regulatory authority audits.