contract automation in drug development

1. Adopting Contract Automation Solutions in
Pharmaceutical Clinical Development to shorten
contract negotiation time and reduce trasnsaction cost
LARRY AJUWON
DIRECTOR, RHIEOS-VENTURES LTD
A summary of informal discussions with industry
c o l l e a g u e s d u r i n g t h e Pa r t n e r s h i p i n C l i n i c a l Tr i a l s
Congress, Vienna, Nov 19-21, 2013 and thoughts
shared on the Contract Express Cloud Solution demo
Rhieos-Ventures Ltd/dealligence.com, 2013

2. Background on Clinical Development Contracting in
Pharmaceutical Industry
 To confirm the safety and efficacy of new drugs and treatments,
pharmaceutical companies and health care organisation must conduct clinical
trials and get approval from regulatory bodies
 The conduct of these trials will involve many parties, including hospitals,
healthcare providers, contract research organisations, central laboratories
and a host of specialist service providers and consultants
 It‘s a regulatory and quality requirement to have the right contracts in place
before any trials can start
 As an example, a pivotal study, (where results are key for a drug‘s approval)
conducted in 10 countries across 30 locations, with 2000 subjects may involve
up to 150 contractual relationships
Rhieos-Ventures Ltd/dealligence.com, 2013

3. Contracting Procedures and Issues
 Contract documents tend to be country, trial and service specific with
Hospitals requiring Pharma companies to use the hospitals‘ templates and
follow their procedures
 Pharma companies in turn want their partners and contractors to accept their
own contract templates, language, and procedures
 Contract drafting and negotiation can be a tedious and time consuming affair
because all parties involved want to make sure any potential issues or risks
are properly covered
 This makes contract set-up to be on the „critical path“ to starting clinical trials
on time and it‘s one of the main causes for delays
Rhieos-Ventures Ltd/dealligence.com, 2013

4. What is contract automation and
how can it help?
 It is the use of technologies like document assembly, work flow systems and
collaboration applications to design and automate contract drafting,
negotiation and execution.
 Richard Susskind, in his book, ‘The End of Lawyers’ recognizes the role of
automation technology in the production of legal documents and regards
Document Assembly as one of 10 'disruptive technologies' that are altering
the face of the legal profession
 At it‘s simplest, it helps parties to select and structure the right building
blocks for a particular contractual relationship and then guides them towards
a reasonable agreement in a timely way
Rhieos-Ventures Ltd/dealligence.com, 2013

5. Implementation options for Contract Automation and
Negotiation Solutions
 Small to Mid size Biotech, Clinics, Consultants
 Contract volume - Low
 Use: CDA, LOIs, Term Sheet, License agreements
 Solution: Cloud based or use outsourced
 Mid-size Pharma , Biotech, Providers and CROs
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Contract volume - Medium
Use: CDA, LOIs, various clinical development contracts
Solution: Company server installation (data privacy concerns)
 Big Pharma, Hospitals and CROs

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Contract volume - High
Use: As above and various clinical development contracts
Solution: Company Server installation (data privacy concerns)
Joint deployment?
Rhieos-Ventures Ltd/dealligence.com, 2013

6. Summary
Based on these conversations as well as from the author‘s own experience,
there is an urgent need for better and smarter ways to do clinical development
contracting. Cycle times can be reduced from months to days ensuring trials
start on time and lowering transaction costs.
-------------------------------------------To see contract automation in action, please feel free to contact me :
nl.linkedin.com/in/larryajuwon/
Acknowledgements
I would like to thank everyone for their thoughts and experiences and to
Business Integrity for helping to set-up a demo tool using their ContractExpress application
Rhieos-Ventures Ltd/dealligence.com, 2013