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Assessing  the  Quality  {Company’s}    Rela7onship  with  its  Inves7ga7ve  Sites    

An  Analysis  of  Company-­‐Specific  Results  From  the  CenterWatch  2013  Survey  of  Global  InvesBgaBve  Sites  

 

SAMPLE  CUSTOM  MARKET  RESEARCH  REPORT  

Slide  #  

Survey  Methodology   3  

A7ributes  Measured   4  

Execu?ve  Summary   7  

Importance  of  Project  A7ributes   9  

General  –  Overall  Rela?onship  Quality  Ra?ng   13  

{Company  Name}  –  Company-­‐Specific  Results   19  

Reputa?on  Ra?ng   99  

Respondent  Profile   101  

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Table  of  Contents  

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Survey  Methodology  The  survey  instrument  used  by  CenterWatch  to  measure  sponsor-­‐site  rela?onship  quality  was  conceived  in  1997  based  on  input  from  representa?ves  from  sponsor  and  CRO  companies,  and  inves?ga?ve  sites.      The  survey  ques?onnaire  was  streamlined  and  op?mized  this  year.    Specifically,  a  few  new  project  a7ributes  were  incorporated  into  the  survey  this  year.    Addi?onally,  a  new  ques?on  was  added  reques?ng  sites  to  evaluate  sponsor  and  CRO  companies  on  overall  reputa?on  in  the  industry.    In  the  2011  global  survey,  Sponsors  were  evaluated  against  a  total  of  29  project  a7ributes.    In  the  2013  global  survey,  Sponsors  were  evaluated  against  a  total  of  36  project  a7ributes.    A  total  of  X    individual  sponsors  were  evaluated  in  the  2013  survey  due  to  the  overall  larger  sample  size  (compared  to  X  CROs  in  the  2011  survey).      For  this  year’s  global  survey,  the  ques?onnaire  was  e-­‐mailed  to  more  than  30,000  sites  across  the  world.    A  total  of  2,032  sites  completed  the  survey,  represen?ng  a  7%  response  rate.    The  majority  of  respondents  originated  from  North  America  and  Europe.    The  survey  was  conducted  during  the  months  of  November/December  2012  and  January  2013.    Approximately  72%  of  the  sample  were  inves?gators,  with  the  remaining  sample  being  study  coordinators  or  administrators.    Survey  respondents  had  an  average  of  12  years  clinical  research  experience.    A  majority  of  the  global  sites  conduct  clinical  research  on  a  part-­‐?me  basis  (57%),  while  43%  reported  full-­‐?me  involvement  in  clinical  research.    In  the  2013  survey,  X    respondents  rated  their  rela?onship  quality  with  {Sponsor  Company}.  

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A7ributes  Measured  OVERALL  PROJECT  SUPPORT  

Timely  drug  availability  

Efficient  query  handling  process  

Professional  medical  staff  

Professional  administra?ve  staff  

Staff  easily  accessible  for  escala?on  of  issues  &  provides  ?mely  and  appropriate  resolu?on*  

Effec?ve  use  of  communica?on  technologies  (web  portals,  IVRS,  etc.)*  

*New  a'ribute  in  2013  

STUDY  MONITORING  SUPPORT  

Professional,  knowledgeable  CRAs  

Low  monitor  turnover  

Responsive  to  inquiries  

Provides  ongoing  help  in  running  the  study  

Is  organized  and  prepared  

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A7ributes  Measured  

*New  a'ribute  in  2013  

PROTOCOL/STUDY  DESIGN  &  PLANNING  

Good  overall  protocol  design  

Protocol  where  ra?onale  aligned  with  clinical  prac?ce  reali?es  

Protocol  requires  minimal  amendments  

Realis?c  project  ?melines  

Realis?c  pa?ent  enrollment  goals  

Uncomplicated  CRF  design  

Realis?c  ?melines  for  CRF  comple?on  and  return*  

INNOVATIVENESS  

U?lizes  technology  to  make  processes  more  efficient  

Is  an  innovator  in  finding  ways  to  improve  rela?onships  with  inves?ga?ve  sites*  

SITE  MANAGEMENT  

Adequate  training  &  guidelines  for  comple?on  of  CRF*  

Adequate  training  support  for  trial*  

Provides  pa?ent  recruitment  planning  &  implementa?on  assistance  

Supports  ini?a?ves  to  build  stronger  rela?onships  with  study  volunteers*  

Holds  informa?ve  inves?gator  mee?ngs  

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A7ributes  Measured  

*New  a'ribute  in  2013  

WORKSTYLE  

Adequately  empowers  staff  to  make  level-­‐appropriate  decisions*  

Effec?vely  works  with  CROs  

Maintains  open  communica?on  

Has  a  suppor?ve  culture  

Creates  a  collabora?ve  team  environment  

CONTRACTS  &  BUDGETS  

Efficient  contract  &  budget  nego?a?on  

Provides  adequate  funding  for  pa?ent  recruitment  

Is  flexible  –  willing  to  modify  protocols/budgets  

Provides  prompt  payment  of  grants  

Offers  realis?c  grant  payment  schedules  

Provides  fair  overall  grant  payment  amounts  

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Execu?ve  Summary  

•  This  slide  will  include  an  Execu?ve  Summary  of  the  survey  results  for  {Sponsor  Company}    

•  What  follows  are  slides  with  charts  detailing  the  data  results  for  each  rela?onship  a7ribute    

•  Reports  usually  range  from  90  –  105  slides  

CHART  INTERPRETATION  

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14%   18%   11%   9%  

39%   35%   42%  36%  

44%   44%   44%   53%  

76%  

0%  

20%  

40%  

60%  

80%  

100%  

Benchmark   Company   Top-­‐Rated  Company  

2011  Company  Ra?ng  

Percent  Ra?ng  Very  Important  

Excellent  

Good  

Neutral  

Fair  

Poor  

Percent  of  Respondents  

Ra?ng  A7ribute  “Very  

Important”  

A7ribute  category  

Company  ra?ng  from  

2011  CenterWatch  Global  Site  Survey  

Company  ra?ng  from  2013  

CenterWatch  Global  Site  Survey  

Top  rated  company  

for  a7ribute  

Average  Sponsor  ra?ng  

OVERALL  PROJECT  SUPPORT  

SAMPLE  DATA