Strategic Approaches to Outsourcing to CRO

1
Strategic Approaches to Outsourcing to Clinical
Research Organizations
Kate Giovino Director of Clinical Operations
2
Experience

• Class III Medical Devices
• Living bi-layered skin substitute
• Spinal implants
• Bone morphogenetic protein

There is tremendous diversity in Medical Devices
3
5 Habits of Highly Effective Device Sponsors

• Establishing SOPs
• Hiring employees with experience in conducting
  clinical studies
• Utilizing a consultant such as a CRO for study
  functions beyond the sponsor's in-house
  capabilities
• Conducting internal and external audits of the
  clinical study processes, procedures and
  personnel
• Review of clinical study issues by management
  with executive responsibilities

• Strategic use of CROs can directly contribute to
  the effectiveness of device sponsors, as assessed
  by these 5 habits.

4
Objectives

• Utilizing a consultant such as a CRO for study
  functions beyond the sponsor's in-house
  capabilities
• What can potentially be outsourced in the conduct
  of clinical trials
• How to decide for your organization
• Lessons learned - sometimes the hard way!

5
General Questions to Ask

• What are the capabilities and capacity of
  existing clinical personnel?
• What are the critical business factors (e.g.,
  time, money, headcount) for the organization?
• What are the long-term needs to support clinical
  development?
• Do they substantiate in-house capabilities?

6
What to Outsource?

• SOP development
• Protocol development
• Monitoring / Project Management
• Data Management / Statistics
• Audits of internal and external of clinical
  processes, procedures and personnel

7
SOP development

• Dependent on other outsourcing decisions
• Highly outsourced ? need for simple SOPs
• Key processes internal ? need for detailed SOPs
• Lessons learned
• Too busy to write SOPs
• Contracted out
• Non-specific and unusable (poor vendor selection)

CenterWatch Standard Operating Procedures for
Good Clinical Practice by Sponsors of Medical
Device Trials (6000)
Expertise of vendor was clinical drug
development, not medical devices
8
Protocol Development

• A well-written and unambiguous protocol is one
  of the key factors in the success of a clinical
  study

Consultation with a Lead Investigator(s)
Clinical operations point of view
HOW WELL DOES YOUR ORGANIZATION ATTEND TO THIS
BALANCE?
9
Monitoring and Project Management
10
Monitoring and Project Management Experiences

• Things that dont work
• Trying to manage ex-US clinical sites/studies
  without in-country clinical expertise.
• Not having in-house experienced clinical research
  personnel to closely oversee any contracted CROs.
• Not having executive management who recognize and
  value the complexities of clinical research and
  are committed to fulfilling their management
  responsibilities.

11
Data Management

• What are the short-term and long-term needs?
• When does it become cost-efficient to bring a
  data management system in-house
• Paper-based or electronic data capture?
• What types of clinical studies are you
  conducting?
• Post-marketing
• Pilot studies
• Pivotal studies
• What would be the key advantages/disadvantages of
  either in-house vs. outsourced data management

12
Data Management IDE Experience
13
Data Management Statistics

• There is GREAT value in having an internal
  person(s) on your team who can speak APPLES TO
  APPLES regarding data management and statistical
  issues.
• Strongly consider this a CORE competency to
  develop internally or with a strongly aligned
  consultant.

14
Internal and External Clinical Audits

• Internal GCP audit
• External audits
• Key vendors (e.g., data management, core labs)
• Clinical Sites

WHAT WHO ARE THE RESOURCES IN YOUR INTERNAL
QUALITY ASSURANCE GROUP ?
15
Internal vs. External Auditors

• Internal Auditors
• Knowledgeable on device and general SOPs
• Level of GCP expertise?
• Co-audit QA Clinical personnel
• Minimal cost
• External Auditors
• High level of GCP expertise
• High degree of independence from Sponsor
• Additional cost

16
Internal GCP Audits

• Assessment of training files
• SOP review with gap analysis
• In anticipation of a Sponsor audit by FDA

17
External Audits - CROs

• Prior to CRO selection (optimal)
• Assessing qualifications of key personnel
• Assessing SOPs comparability with internal SOPs
  and change control processes
• Reviewing systems and processes for contracted
  services
• Audits at other times
• Routine, on-going basis
• Prior to interim and/or final analysis
• For cause.

18
External Audits Clinical Sites

• Mock Audits Prior to Final Database Lock
• Why Now?
• Last opportunity to take a systematic look at the
  quality of the data
• How?
• Quality Assurance department or CRO
• Allow enough time to respond to the findings of
  the audits
• Which Sites?
• High enrolling sites, compliance concerns, or
  extremely high or low incidence of AEs

19
5 Habits of Highly Effective Device Sponsors
CRO involvement

• Establishing SOPs
• Hiring employees with experience in conducting
  clinical studies
• Utilizing a consultant such as a CRO for study
  functions beyond the sponsor's in-house
  capabilities
• Conducting internal and external audits of the
  clinical study processes, procedures and
  personnel
• Review of clinical study issues by management
  with executive responsibilities

• YES ? with customization to your organization
• Need core expertise in your organization to
  oversee and manage CROs
• YES ? with careful selection of CRO and
  thoughtful decisions regarding which functions to
  outsource
• YES ? especially when internal QA resources are
  limited or GMP/GLP focused
• NO ? Must be a retained responsibility within
  your organization

20
CONCLUSIONS

• Decide on an approach that meets the needs of
  your organization considering the following
• Competencies and capacity of in-house clinical
  personnel
• Key business needs
• Carefully select your CRO to match the needs of
  your organization
• Alignment with values, priorities and needs

21

• Further questions
• Kate Giovino
• kgiovino_at_organo.com
• 781-401-1136