Adopting Contract Automation Solutions in
Pharmaceutical Clinical Development to shorten
contract negotiation time and red...
Background on Clinical Development Contracting in
Pharmaceutical Industry
 To confirm the safety and efficacy of new drug...
Contracting Procedures and Issues
 Contract documents tend to be country, trial and service specific with

Hospitals requ...
What is contract automation and
how can it help?
 It is the use of technologies like document assembly, work flow systems...
Implementation options for Contract Automation and
Negotiation Solutions
 Small to Mid size Biotech, Clinics, Consultants...
Summary

Based on these conversations as well as from the author‘s own experience,
there is an urgent need for better and ...
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Adopting contract automation solution in clinical development.,, a plausible proposition?

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Adopting contract automation solution in clinical development.,, a plausible proposition?

  1. 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. 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. 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. 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. 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    Contract volume - Medium Use: CDA, LOIs, various clinical development contracts Solution: Company server installation (data privacy concerns)  Big Pharma, Hospitals and CROs     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. 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

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