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1
Implementing Quality
By Design with
Outsourced Partners:
Challenges and
Solutions
Janis Hall
Janis.Hall@theavocagroup.com
2
● The	
  Avoca	
  Group	
  and	
  Avoca	
  Quality	
  Consor7um	
  (AQC)	
  
● AQC	
  Quality	
  Oversight	
  Framework	...
33
Who	
  is	
  The	
  Avoca	
  Group?	
  	
  
•  The	
  Avoca	
  Group,	
  Inc.,	
  founded	
  in	
  1999,	
  is	
  a	
  ...
44
5
Quality Oversight Framework for
Proactive Quality Management
Governance/
Organizational
Construct
Governance
Sourcing Mo...
6
Best Practices for Proactive Quality Management and
Quality Oversight
Process	
  Oversight	
  Guideline	
  
•  Process	
...
7
Quality by Design Terms and Definitions
QbD-­‐	
  is	
  an	
  approach	
  to	
  development	
  that	
  begins	
  with	
 ...
8
Quality by Design- Terms and Definitions
RBM	
  (Risk-­‐Based	
  Monitoring)-­‐	
  	
  (FDA	
  Aug	
  2013	
  Guidance)	...
9
Quality by Design Terms and Definitions
Source	
  Data	
  Verifica8on	
  (SDV)	
  vs.	
  Source	
  Data	
  Review	
  (SDR...
10
Implementing QbD with Outsourced
Partners: Challenges (1)
New,	
  evolving	
  thinking	
  
•  Concepts	
  are	
  new	
 ...
11
Implementing QbD with Outsourced
Partners: Challenges (2)
Culture,	
  behaviors	
  and	
  resources	
  
•  Tradi7onal	
...
12
How would you rate your current understanding of
QbD processes, as applied to clinical development?
Only approximately ...
13
How would you rate your company’s current application
of QbD principles in clinical development?
CRO respondents were m...
14
On average, how satisfied are you with your own company’s or your
counterpart’s implementation of these key practices o...
15
Industry Status in Applying QbD Methods
Broad	
  use	
  
15%	
  
New	
  user	
  
19%	
  
Pilot	
  one	
  
trial	
  
10%...
16
Industry Status in Applying QbD Methods
	
  Yes	
  
44%	
  
	
  No	
  
23%	
  
	
  Unsure/Don't	
  
know	
  
33%	
  
Ha...
17
Industry Status in Applying QbD Methods
0%	
  
10%	
  
20%	
  
30%	
  
40%	
  
50%	
  
60%	
  
70%	
  
80%	
  
	
  Clin...
18
Industry Status in Applying QbD Methods
	
  Internal	
  –	
  culture	
  
(risk	
  averse)	
  
10%	
  
	
  Internal-­‐	
...
19
Implementing QbD Approaches with
Outsourced Partners
	
  	
  
CROs	
  and	
  Sponsors	
  should	
  	
  
1.  Assess	
  s...
20
Solutions when Outsourcing:
Supplier Expertise Assessment (1)
	
  	
  
● Need	
  for	
  transparency	
  since	
  this	
...
21
Solutions when Outsourcing:
Supplier Expertise Assessment (2)
How	
  to	
  assess	
  knowledge,	
  experience,	
  exper...
22
Solutions when Outsourcing:
Supplier Risk Assessments (1)
2.	
  Sponsors	
  and	
  CROs	
  should	
  deploy	
  best	
  ...
23
Solutions when Outsourcing:
Supplier Risk Assessments (2)
2.	
  Sponsors	
  and	
  CROs	
  should	
  deploy	
  best	
  ...
24
Solutions when Outsourcing:
Supplier Risk Assessments (2)
2.	
  Sponsors	
  and	
  CROs	
  should	
  deploy	
  best	
  ...
25
Solutions when Outsourcing:
Supplier Risk Assessments (2)
2.	
  Sponsors	
  and	
  CROs	
  should	
  deploy	
  best	
  ...
26
Solutions when Outsourcing:
Supplier Risk Assessments (2)
2.	
  Sponsors	
  and	
  CROs	
  should	
  deploy	
  best	
  ...
27
Solutions when Outsourcing: Joint
Collaboration for Implementation (1)	
  	
  
Joint	
  collabora7on	
  with	
  partner...
28
Solutions when Outsourcing: Joint
Collaboration for Implementation (2)	
  	
  
Joint	
  collabora7on	
  with	
  partner...
29
Solutions when Outsourcing: Joint
Collaboration for Implementation (3)	
  
Joint	
  collabora7on	
  with	
  partners	
 ...
30
Solutions when Outsourcing:
Build QbD into Contracts (1)
	
  	
  
CROs	
  and	
  Sponsors	
  should	
  	
  build	
  QbD...
31
Solutions when Outsourcing:
Build QbD into Contracts (2)
	
  	
  
CROs	
  and	
  Sponsors	
  should	
  	
  build	
  QbD...
32
Implementing QbD Approaches with
Outsourced Partners
	
  	
  
CROs	
  and	
  Sponsors	
  should	
  	
  
1.  Assess	
  s...
33
QbD Best Practices: Key Messages
	
  	
  
●  Paradigm	
  shif	
  
●  Fit	
  for	
  GCP	
  ac7vi7es/clinical	
  trials	
...
34
35
Thank you!
Janis.Hall@theavocagroup.com
1-252-676-3103
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Clinical QbD Best Practices When Outsourcing

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Implementing Quality by Design with Outsourced Partners: Challenges and Solutions

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Clinical QbD Best Practices When Outsourcing

  1. 1. 1 Implementing Quality By Design with Outsourced Partners: Challenges and Solutions Janis Hall Janis.Hall@theavocagroup.com
  2. 2. 2 ● The  Avoca  Group  and  Avoca  Quality  Consor7um  (AQC)   ● AQC  Quality  Oversight  Framework  and  Process  Oversight   ● Quality  by  Design  Best  Prac7ces  Guideline  and  Tools   ● Terminology  and  Defini7ons   ● Implemen7ng  QbD  with  Outsourced  Partners:  Challenges   ● Industry  Status  Applying  QbD  Methods  for  Clinical  Trials   ● Implemen7ng  QbD  with  Outsourced  Partners:  Solu7ons   ● Key  Messages  and  Conclusions   ● Resources  and  References  list   Topics Implementing QbD with Outsourced Partners: Challenges and Solutions
  3. 3. 33 Who  is  The  Avoca  Group?     •  The  Avoca  Group,  Inc.,  founded  in  1999,  is  a  consul7ng  and  survey   research  firm  that  develops  and  implements  global  rela7onship  and   alliance  management  programs  for  biopharmaceu7cal  companies  and   pharmaceu7cal  service  providers.     The Avoca Group The Avoca Quality Consortium What  is  The  Avoca  Quality  Consor8um?     •  Founded  in  2011.  Today  the  Consor7um  has  over  35  biopharm  and  CRO   member  companies.     •  Purpose:  Help  companies  op7mize  their  approaches  to  proac7ve  quality   management  with  an  emphasis  on  bringing  sponsors  and  CROs  into   greater  alignment.   •  Vision:  To  serve  as  a  catalyst  for  the  accelera7on  of  best  prac7ces  and   industry  standards  for  proac7ve  quality  management.  
  4. 4. 44
  5. 5. 5 Quality Oversight Framework for Proactive Quality Management Governance/ Organizational Construct Governance Sourcing Models Committee Construct Decision Models Ctrs of Excellence Teams/Functions Quality Units Issue Escalation Technical/ Project Oversight Functional Project Team Business Technology Process Oversight Delegated Processes Shared Processes QbD Principles QMP Process Development/ Improvement Communication Communication Communication Plan Escalation Plan Oversight Leadership Requirements Leadership Leadership Styles Oversight Leadership Characteristics Talent Management Metrics / Analytics / Technology Leading Indicators KPIs KQIs Desktop On- Demand Real Time Accuracy Roles / Responsibilities Sponsor Oversight Sponsor Operations CRO Oversight CRO Operations Proactive Risk / Opportunity Management Risk Identification Risk Management Opportunity Management Quality Risk Plans Timeline Risk Plans Cost Risk Plans Recovery or Transition Plans Governance Sourcing Models Committee Construct Decision Models Ctrs of Excellence Teams/Functions Quality Units Issue Escalation Communication Communication Plan Escalation Plan Leadership Leadership Styles Oversight Leadership Characteristics Talent Management Governance Sourcing Models Committee Construct Decision Models Ctrs of Excellence Teams/Functions Quality Units Issue Escalation Technical/ Project Oversight Functional Project Team Business Technology Process Oversight Delegated Processes Shared Processes QbD Principles QMP Process Development/ Improvement Communication Communication Plan Escalation Plan Leadership Leadership Styles Oversight Leadership Characteristics Talent Management Metrics / Analytics / Technology Leading Indicators KPIs KQIs Desktop On- Demand Real Time Accuracy Roles / Responsibilities Sponsor Oversight Sponsor Operations CRO Oversight CRO Operations Proactive Risk / Opportunity Management Risk Identification Risk Management Opportunity Management Quality Risk Plans Timeline Risk Plans Cost Risk Plans Recovery or Transition Plans Governance/ Organizational Construct Governance Sourcing Models Committee Construct Decision Models Ctrs of Excellence Teams/Functions Quality Units Issue Escalation Communi- cation Communication Communication Plan Escalation Plan Oversight Leadership Requirements Leadership Leadership Styles Oversight Leadership Characteristics Talent Management Completed   In  Development   Planned  for  2014   Process Selection
  6. 6. 6 Best Practices for Proactive Quality Management and Quality Oversight Process  Oversight  Guideline   •  Process  Tool-­‐1-­‐  Elements  of  Process  Oversight   •  Process  Tool-­‐4-­‐  Quality  by  Design  Principles     •  Process  Tool-­‐1a-­‐  Task  Ownership  Matrix     •  Process  Tool-­‐4a-­‐  QbD  for  Pharma  GMP  Ac8vi8es     •  Process  Tool-­‐1b-­‐  Template  Task  Ownership  Matrix   •  Process  Tool-­‐4b-­‐  QbD  for  Pharma  GCP  Ac8vi8es   •  Process  Tool-­‐2-­‐  Transfer  of  Regulatory  Obliga8ons   •  Process  Tool-­‐4c-­‐  Opera8onalizing  QbD  for  Clinical  Trials   •  Process  Tool-­‐2a-­‐  Template  Transfer  of  Regulatory  Obliga8ons   •  Process  Tool-­‐4d-­‐  QbD  Template  CTQ  Table   •  Process  Tool-­‐3-­‐  Process  Document  Control   •  Process  Tool-­‐4e-­‐  QbD  Template  IMP  Interven8on  Risk   •  Process  Tool-­‐3a-­‐  Process  Tracking  Table   •  Process  Tool-­‐4f-­‐  QbD  Template  Design  and  Methods  Risk   •  Process  Tool-­‐3b-­‐  Joint  Process  Development   •  Process  Tool-­‐4g-­‐  QbD  Template  FMEA     •  Process  Tool-­‐3c-­‐  Six  Sigma  SIPOC  Tool   •  Process  Tool-­‐4h-­‐  QbD  Best  Prac8ces  when  Outsourcing   •  Process  Tool-­‐3d-­‐  Six  Sigma  Swim  Lane  Tool   •  Process  Tool-­‐4i-­‐  QbD  Supplier  Risk  Assessment   •  Process  Tool-­‐3e-­‐  Template  for  Joint  Process  Documenta8on   •  Process  Tool-­‐5-­‐  Joint  Quality  Management  Plan   •  Process  Tool-­‐3f-­‐  Process  Improvement   •  Process  Tool-­‐5a-­‐  Supplier  Assessment  Report  Template   •  Process  Tool-­‐3g-­‐  Lean  and  Kaizen  Events   •  Process  Tool-­‐5b-­‐  Central  Supplier  Assessment  Tracking  Table   •  Process  Tool-­‐3h-­‐Root  Cause  Analysis   •  Process  Tool-­‐5c-­‐  Project  Supplier  Tracking   •  Process  Tool-­‐3i-­‐Template  RCA  Fishbone  Diagram   •  Process  Tool  5d-­‐  Approved  Supplier  List   •  Process  Tool-­‐3j-­‐Sta8s8cal  Process  Control-­‐  Control  Chart   •  Process  Tool-­‐6-­‐  Change  Management  Best  Prac8ces     •  Process  Tool-­‐3k-­‐Process  Mapping  Instruc8ons   •  Process  Tool  6a-­‐  Change  Management  Plan  Template   Focus  for  Presenta7on   Quality  by  Design  Best   Prac7ces  
  7. 7. 7 Quality by Design Terms and Definitions QbD-­‐  is  an  approach  to  development  that  begins  with  predefined  objec7ves  and   emphasizes  product  and  process  understanding  and  process  control,  based  on  sound   science  and  quality  risk  management  (ICH  2009)       Design  space-­‐  the  mul7dimensional  combina7on  and  interac7on  of  input  variables   and  process  parameters  that  have  been  demonstrated  to  provide  assurance  of  quality;   when  defining  a  design  space,  the  applicant  should  keep  in  mind  the  type  of  opera7onal   flexibility  desired.  (ICH  Q8  R1)     Cri8cal-­‐to-­‐Quality  (CTQ)  is  an  aXribute  of  a  product  or  process  that  has  a  direct  and   significant  impact  on  its  actual  or  perceived  quality  and  should  be  within  an   appropriate  limit,  range,  or  distribu7on  to  ensure  the  desired  quality  (derived  from  ICH   Q8  R1)  
  8. 8. 8 Quality by Design- Terms and Definitions RBM  (Risk-­‐Based  Monitoring)-­‐    (FDA  Aug  2013  Guidance)  “monitoring”  refers  to  the   methods  used  by  sponsors  (or  CROs)  to  oversee  the  conduct  of  and  repor7ng  of  data  from   clinical  inves7ga7ons,  including  appropriate  clinical  inves7gator  supervision  of  study  site   staff  and  third  party  contractors.       Centralized  vs.  On-­‐site  vs.  Off-­‐site  (remote)  site  monitoring   ●  Centralized  monitoring-­‐  A  “remote  evalua7on  carried  out  by  sponsor  personnel  or   representa7ves  (e.g.  Data  Manager,  Sta7s7cian,  or  Monitor)”  (FDA  Guidance).         ●  On-­‐site  Monitoring-­‐  An  in-­‐person  evalua7on  carried  out  by  sponsor  personnel  or   representa7ve(s)  at  the  site(s)  at  which  the  clinical  inves7ga7on  is  being   conducted”  (FDA  Guidance).       ●  Off-­‐site  Monitoring-­‐  Monitoring  ac7vi7es  as  defined  either  within  process   documents  or  in  the  monitoring  plan  that  occur  away  from  the  study  site  loca7on   (TransCelerate)    
  9. 9. 9 Quality by Design Terms and Definitions Source  Data  Verifica8on  (SDV)  vs.  Source  Data  Review  (SDR)  (TransCelerate)   SDV-­‐    data  within  the  CRF  (or  other  data  collec7on  systems)  are  compared  to  the   original  source  to  confirm  that  the  data  were  transcribed  accurately  (i.e.  source   data  vs.  data  in  the  CRF)   SDR*-­‐  review  source  documenta7on  to  check  quality  of  source,  review  protocol   compliance,  ensure  the  Cri7cal  Processes  and  source  documenta7on  (e.g.   accurate,  legible,  complete,  7mely,  dated)  are  adequate,  to  ascertain   Inves7gator  involvement  and  appropriate  delega7on,  and  assess  compliance  to   other  areas  (e.g.  SOPs,  GCP).  .  .  not  a  comparison  of  source  data  against  CRF   data.  .  .  .  necessary  to  evaluate  areas  that  do  not  have  an  associated  data  field  in   the  CRF  or  system  available  for  more  7mely  remote  review.     *Requires  cri8cal  thinking  skills  and  judgment  
  10. 10. 10 Implementing QbD with Outsourced Partners: Challenges (1) New,  evolving  thinking   •  Concepts  are  new  and  developing     •  Not  established  as  standard  prac7ces   •  Imbalance  of  knowledge,  experience  and  acceptance   •  Concepts  not  equally  mature  across  clinical  trial  process     •  High  profile  and  poten7al  for  high  expecta7ons  beyond  capabili7es   Stakeholders  Engagement/Understanding/Capabili7es   •  Not  all  stakeholders  are  engaged   •  Sponsor/Supplier/Inves7gators   •  Unequal  understanding/commitment/involvement  with  methods   development   •  Func7onal  area  and  geographic  imbalance  of  understanding  
  11. 11. 11 Implementing QbD with Outsourced Partners: Challenges (2) Culture,  behaviors  and  resources   •  Tradi7onal  risk  averse  behavior-­‐  Paradigm  shif-­‐focus  on  high  risk  factors   •  Staff  challenges   •  “Hard-­‐wired”     •  Reluctant,  unwilling  or  unable  to  change   •  Func7onal  area  imbalance  of  knowledge   •  Poten7al    reassignment  or  removal  of  resources  to  fit  new  needs   •  Sponsors/CROs     •  “Walk  the  talk”   •  Demonstrate  tolerance  of  low  risk  events   •  Reinforce/reward/recognize  adop7on   Contracts   •  Transparency     •  Complexity  vs.  tradi7onal   •  Flexibility  
  12. 12. 12 How would you rate your current understanding of QbD processes, as applied to clinical development? Only approximately half of the respondents stated that they had at least a “good understanding” of QbD processes, as applied to clinical development. 10% 14% 40% 43% 43% 39% 7% 4% 0% 20% 40% 60% 80% 100% Sponsors CROs Very strong understanding Good understanding Fair understanding Poor understanding N 235 153 Data from 2014 Interim AQC Research
  13. 13. 13 How would you rate your company’s current application of QbD principles in clinical development? CRO respondents were more likely than sponsor respondents to report frequent or consistent application of QbD principles in clinical development, but sponsors don’t appear to be very aware of CRO’s application of these approaches. 9% 2% 19% 31% 22% 38% 48% 55% 38% 12% 20% 4% 0% 20% 40% 60% 80% 100% Sponsors re own companies Sponsors re their clinical service providers CROs Consistent application Frequent application Inconsistent application Little application N 228 228 144 Data from 2014 Interim AQC Research
  14. 14. 14 On average, how satisfied are you with your own company’s or your counterpart’s implementation of these key practices of quality and risk management? Sponsors re own company CROs re sponsors CROs re own company Sponsors re CROs N= 231 136 150 218 Quality planning overall 3.5 3.3 3.8 3.0 Quality control overall 3.6 3.4 3.8 3.1 Quality improvement overall 3.5 3.2 3.8 3.0 Use of Failure Mode Effects Analysis (FMEA) methodology 3.1 2.9 3.1 2.7 Proactive risk assessment overall 3.3 3.1 3.7 2.7 Design of training materials, monitoring plan, audit plan, data management plan, taking into account identified risks 3.5 3.3 3.8 3.2 Adaptation of safety monitoring plan according to trial-specific risks 3.6 3.4 3.7 3.3 Adjustment of conventional GCP methods to identified risks (e.g. on-site vs. central monitoring; targeted source document verification) 3.4 3.2 3.7 3.1 Proactive risk mitigation overall 3.3 3.2 3.6 2.8 For QbD-related practices, mean ratings among sponsor and CRO respondents were generally in the neutral to satisfied range, with each group feeling more positively about its own practices than about its partners’ practices. Data from 2014 Interim AQC Research
  15. 15. 15 Industry Status in Applying QbD Methods Broad  use   15%   New  user   19%   Pilot  one   trial   10%   Establishing   infrastructure   29%   No  plans  to  use   8%   Unsure/Don't   know   19%   Is  your  organiza8on  applying  QbD  methods  for   clinical  research  and  if  so,  to  what  degree?     (select  one)  N=52   Survey  data  gathered  March  21  and  26,  2014  during  an  Avoca   Quality  Consor7um  Quarterly  Webinar:  QbD  Best  Prac7ces  
  16. 16. 16 Industry Status in Applying QbD Methods  Yes   44%    No   23%    Unsure/Don't   know   33%   Has  your  organiza8on  used  QbD  approaches  for   assessing  protocol  risk?  (select  one)  N=48   Survey  data  gathered  March  21  and  26,  2014  during  an  Avoca   Quality  Consor7um  Quarterly  Webinar:  QbD  Best  Prac7ces  
  17. 17. 17 Industry Status in Applying QbD Methods 0%   10%   20%   30%   40%   50%   60%   70%   80%    Clinical  program   planning    Protocol  design    Data  collec7on    Site  monitoring    Pharmacovigilance    Other    Not  applying   methods  yet   Is  your  organiza8on  applying  QbD  methods  to  any  of  these  areas?   (Check  all  that  apply)  N=43   Survey  data  gathered  March  21  and  26,  2014  during  an  Avoca  Quality   Consor7um  Quarterly  Webinar:  QbD  Best  Prac7ces  
  18. 18. 18 Industry Status in Applying QbD Methods  Internal  –  culture   (risk  averse)   10%    Internal-­‐  infrastructure   (tools/systems)   24%    Internal-­‐  skills  (right   resources/training)   19%    Internal-­‐  other   2%    External-­‐  inves7gator/ site  (capabili7es/ knowledge)   5%    External-­‐  suppliers   (capabili7es/knowledge)   14%    External-­‐  other   2%    Not  applying  QbD   methods  yet   24%   As  a  sponsor  or  CRO  organiza8on,  when  it  comes  to  applying  QbD   methods,  what  is  your  greatest  challenge?  (select  one)  N=42   Survey  data  gathered  March  21  and  26,  2014  during  an  Avoca  Quality   Consor7um  Quarterly  Webinar:  QbD  Best  Prac7ces  
  19. 19. 19 Implementing QbD Approaches with Outsourced Partners     CROs  and  Sponsors  should     1.  Assess  suppliers  for  knowledge,  experience  and   exper7se  implemen7ng  QbD  methods   2.  Deploy  best  prac7ces  for  conduc7ng  supplier  risk   assessments  for  outsourced  services     3.  Joint  collabora7on  with  partners  to  ensure  appropriate   implementa7on  of  QbD  processes   4.  Build  QbD  methodologies  into  vendor  contracts  
  20. 20. 20 Solutions when Outsourcing: Supplier Expertise Assessment (1)     ● Need  for  transparency  since  this  is  a  rapidly  evolving  space   ● Balance  of  knowledge   ● CRO  has  more  experience  than  sponsor   ● Sponsor  has  more  experience  than  CRO   ● Level  set  knowledge  and  expecta7ons  before  commiong   to  working  together   1.  Assess  suppliers  for  knowledge,  experience,  exper7se   implemen7ng  QbD  methods  
  21. 21. 21 Solutions when Outsourcing: Supplier Expertise Assessment (2) How  to  assess  knowledge,  experience,  exper7se  implemen7ng   QbD  methods?   ● Capabili7es  presenta7ons   ● Case  studies   ● Technology   ● Training/Resource  assignments   ● Tools/templates   ● Integra7on  into  their  infrastructure   ● Expert  group  par7cipa7on   ● Publica7ons/white  papers   ● Speaking  at  conferences   1.  Assess  suppliers  for  knowledge,  experience,  exper7se   implemen7ng  QbD  methods  
  22. 22. 22 Solutions when Outsourcing: Supplier Risk Assessments (1) 2.  Sponsors  and  CROs  should  deploy  best  prac7ces  for   conduc7ng  supplier  risk  assessments  for  outsourced  services     Derived  from  M.  Fields,  Seaqle  Gene7cs   presenta7on  on  protocol  complexity  Aug   2011-­‐  Clinical  Quality  Oversight   Conference  
  23. 23. 23 Solutions when Outsourcing: Supplier Risk Assessments (2) 2.  Sponsors  and  CROs  should  deploy  best  prac7ces  for   conduc7ng  supplier  risk  assessments  for  outsourced  services     iiDerived  from  K.  Sprenger,  Pfizer,  Oct  2013  CTTI  Presenta7on  
  24. 24. 24 Solutions when Outsourcing: Supplier Risk Assessments (2) 2.  Sponsors  and  CROs  should  deploy  best  prac7ces  for   conduc7ng  supplier  risk  assessments  for  outsourced  services    
  25. 25. 25 Solutions when Outsourcing: Supplier Risk Assessments (2) 2.  Sponsors  and  CROs  should  deploy  best  prac7ces  for   conduc7ng  supplier  risk  assessments  for  outsourced  services    
  26. 26. 26 Solutions when Outsourcing: Supplier Risk Assessments (2) 2.  Sponsors  and  CROs  should  deploy  best  prac7ces  for   conduc7ng  supplier  risk  assessments  for  outsourced  services    
  27. 27. 27 Solutions when Outsourcing: Joint Collaboration for Implementation (1)     Joint  collabora7on  with  partners  to  ensure  implementa7on  of  QbD   processes   ● Seong  Expecta7ons   ● QbD  Roles  and  Responsibili7es   ● QbD  across  Clinical  Trial  Process   ● Clinical  Program   ● Study  Design/Protocol  Development  (Process  Tools  4e/4f)   ● Study  Execu7on   ● Data  Management   ● Sta7s7cal  Analysis  and  Repor7ng   ● Medical  Wri7ng   3.  Joint  collabora7on  with  partners  to  ensure  appropriate   implementa7on  of  QbD  processes  
  28. 28. 28 Solutions when Outsourcing: Joint Collaboration for Implementation (2)     Joint  collabora7on  with  partners  to  ensure  implementa7on  of  QbD   processes   ● Seong  Expecta7ons   ● QbD  Roles  and  Responsibili7es   ● QbD  across  Clinical  Trial  Process   ● Clinical  Program   ● Study  Design/Protocol  Development  (Process  Tools  4e/4f)   ● Study  Execu7on   ● Data  Management   ● Sta7s7cal  Analysis  and  Repor7ng   ● Medical  Wri7ng   3.  Joint  collabora7on  with  partners  to  ensure  appropriate   implementa7on  of  QbD  processes  
  29. 29. 29 Solutions when Outsourcing: Joint Collaboration for Implementation (3)   Joint  collabora7on  with  partners  to  ensure  implementa7on  of  QbD   processes   ● Seong  Expecta7ons   ● QbD  Roles  and  Responsibili7es   ● QbD  across  Clinical  Trial  Process   ● Clinical  Program   ● Study  Design/Protocol  Development  (Process  Tools  4e/4f)   ● Study  Execu7on   ● Data  Management   ● Sta7s7cal  Analysis  and  Repor7ng   ● Medical  Wri7ng   3.  Joint  collabora7on  with  partners  to  ensure  appropriate   implementa7on  of  QbD  processes  
  30. 30. 30 Solutions when Outsourcing: Build QbD into Contracts (1)     CROs  and  Sponsors  should    build  QbD  methodologies  into   vendor  contracts     ● Transparency,  complexity,  flexibility-­‐  document  it   ● Task  ownership  matrix     ● Statement  of  Work   ● Contract   4.  CROs  and  Sponsors  should    build  QbD  methodologies  into   vendor  contracts  
  31. 31. 31 Solutions when Outsourcing: Build QbD into Contracts (2)     CROs  and  Sponsors  should    build  QbD  methodologies  into   vendor  contracts     ● Transparency,  complexity,  flexibility-­‐  document  it   ● Task  ownership  matrix  (Process  Tools  1a/1b)   ● Statement  of  Work   ● Contract   4.  CROs  and  Sponsors  should    build  QbD  methodologies  into   vendor  contracts  
  32. 32. 32 Implementing QbD Approaches with Outsourced Partners     CROs  and  Sponsors  should     1.  Assess  suppliers  for  knowledge,  experience  and   exper7se  implemen7ng  QbD  methods   2.  Deploy  best  prac7ces  for  conduc7ng  supplier  risk   assessments  for  outsourced  services     3.  Joint  collabora7on  with  partners  to  ensure  appropriate   implementa7on  of  QbD  processes   4.  Build  QbD  methodologies  into  vendor  contracts  
  33. 33. 33 QbD Best Practices: Key Messages     ●  Paradigm  shif   ●  Fit  for  GCP  ac7vi7es/clinical  trials   ●  Health  authori7es  accept/expect  risk-­‐based  approaches  to  be  applied   ●  Industry  is  developing  methods  and  tools     ●  This  new  approach  is  a  BIG  WIN:     ●  Prac7cal  and  sustainable   ●  Cost  containment   ●  Improve  quality   ●  Increase  safety   ●  Improve  data  integrity   ●  Drive  more  quality  submissions   ●  Drive  more  product  approvals-­‐  WHICH  IS  WHAT  WE  DO  
  34. 34. 34
  35. 35. 35 Thank you! Janis.Hall@theavocagroup.com 1-252-676-3103

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