Best Practice Guidelines

Best  Practice  Guidelines for  PPs  and  PDPs in  Clinical  Trials

Introduction  Best  Practice  Guidance  for  PPs  and  PDPsWhat  Works  and  What  Doesn’tStudy  Phases  Service  Areas

Best   Contracts and Timelines and Effective General Practice   Amendments Deliverables Partnership Challenges Key   Identified using 5 years of PP evaluation data from PP and PDP Themes   surveys that highlighted common issues faced by PPs and PDPsKey  Study   conducting clinical trials Phases

Best  Practices  to  Mitigate  Key  Challenges Contract   Timelines     and   and  Amendments Deliverables Effective   General  Partnership Challenges

Contract  ImplementationAim  for  56-­‐84  days  from  initiation  of  RFP  process  to  contract  signature

Why  56-­‐84  days?Issue:   350 Time  to  Contract  Execution  in  Days  Delayed  contract   300negotiation   DAYS  to  Contract   250 Aim  for  56-­‐84  days  from  and  change  orders   200 initiation  of  RFP  process  to  can  be   150 contract  signaturedisruptive   100to  the  clinical  trial  process 50 0 0 10 20 30 40 50 60 70 80 Contracts  Evaluated   *Note:  This  slide  describes  all  contracts  from   (n=77)* 2009-­‐ 2015?,  irrespective  of  contract  type.

What  causes  contract  delays?PDP  legal  slow/backed-­‐upCRO  responsible  party  not  clearly  identifiedBack  and  forth  negotiations3rd  party  agreements  take  longerMaster  Service  Agreements  take  longer  to  negotiateMany  references  to  ‘start-­‐up  agreements’,  letters  of  intent,and  other  short  term  mechanisms  during  prolonged  evaluations

7  Steps  to  Best  Practices Best  Practices1.  Create  robust  Request  for  Proposal  (RFP)2.  Discuss  Scope  of  Work  (SOW)  and  budget  with  vendors prior  to  CRO  selection3.  Be  mindful of  practical  considerations4.  Set clear  expectations  and  industry-­‐standard  timelines  for  contract  signature5.  Define  responsibilities  for  contract  execution6.  Review  historical  data,  apply  lessons  learned7.  Use  common  terminology  to  define  deliverables  or milestones

Why  Create  Robust  RFPs?Complete,  accurate  RFPs  –>  complete,  accurate  and  timely  proposals

Create  Robust  RFP  1.  Use  Standard  Templates.2.  Define  Roles  and  Responsibilities  not  included  in  RFP.3.  Define  RFP  Timelines.  Meet  industry  standards.4.  Ensure  Scope  of  Work  (SOW)  is  well  defined.

Scope  of  Work  (SOW)Conduct  detailed  discussionof  SOW  and  budget  withvendors  prior  to  CRO  selection,  to  confirm  that  bothinterpretations  of  SOW  are  aligned.  

SOW  Discussions  and  BenefitsDiscuss  implications  of work  pauses,  enrollment  delays,  product  holds  or  postponements  Discuss  expectations  around  vendor  oversight  and  managementPotential  Benefits:More  efficient  contract  implementationFewer  contract  changes/amendments  in  the  future

Practical  Considerations  During  RFP  Process Sign  NDA  earlyFeedback  to   Incorporate  non-­‐winning   MSA  and  SLA biddersPlan  for  F2F   Consider  impact   meetings of  protocol   amendments

Timelines• Set  clear  expectations  and  industry   standard  timeline  for  contract  execution• Aim  for  56-­‐84  days  (8-­‐12  weeks)  from   initiation  of  RFP  process  to  contract   signature• Include  sufficient  time  to  accommodate   different  types  of  agreements  (e.g.,  MSA,   SUA,  LOI,  quality,  3rd  party)

Best  Practices  Continued• Define  responsibilities  for  contract  execution Including  clinical  operations  and  legal  groups Discuss  resourcing  availability  with  legal  groups  at  PDP  and  PP  in   advance• Review  historical  data  for  patterns/number  of  change  orders  and   amendments  • Apply  lessons  learned  early• Common  terminology  to  define  deliverables  or  milestones  that   represent  a  met  expectation• Sign-­‐off  on  payment

You  have  now  completed  this  presentation.

CreditsSlide  3,  by  GHCC  PP?Slide  5,  Photo  CC0  by Cytonn  Photography on UnsplashSlide  6,  Graph  by  GHCC  PP?Slide  7,  Image  CC0  by  Nile  on  PixabaySlide  9,  Image  CC0  by  Cytonn Photography  on  PexelsSlide  11,  Image  CC0  by  Rawpixel on  PixabaySlide  14,  Image  CC0  by  Rawpixel  on  Pixabay