strategic approaches to outsourcing to clinical research organizations kate giovino director of...
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Strategic Approaches to Outsourcing to Clinical Research Organizations
Kate Giovino
Director of Clinical Operations
Experience
Class III Medical DevicesLiving bi-layered skin substituteSpinal implantsBone morphogenetic protein
There is tremendous diversity in Medical Devices
5 Habits of Highly Effective Device Sponsors
1. Establishing SOPs2. Hiring employees with
experience in conducting clinical studies
3. Utilizing a consultant such as a CRO for study functions beyond the sponsor's in-house capabilities
4. Conducting internal and external audits of the clinical study processes, procedures and personnel
5. 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.
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!
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?
What to Outsource?
SOP developmentProtocol developmentMonitoring / Project ManagementData Management / StatisticsAudits of internal and external of clinical processes,
procedures and personnel
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)
Expertise of vendor was clinical drug development,
not medical devices
CenterWatch: Standard Operating Procedures for Good Clinical Practice by
Sponsors of Medical Device Trials ($6000)
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?
Monitoring and Project Management
Monitors Advantages
Internal Familiarity with investigational device / indication for useDirect relationship with InvestigatorsDirect management of clinical trial
External Headcount friendlyDecreased travel costs (regionally based)Ability to hire well-qualified clinical professionals
Monitoring and Project Management Experiences
Things that don’t 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.
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
Data Management – IDE Experience
Data Management Comments
CRO Long-term relationship across multiple clinical programs
In-house (21 CFR Part 11 compliant)
Significant development and validation time and offset by number of studies and decreased data management costs overall
CRO Internal Clinical Project Manager - Biometrics overseeing CRO
In-house (Oracle Clinical) Implemented by multiple divisions within a large orthopedic company
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.
Internal and External Clinical Audits
Internal GCP auditExternal audits
Key vendors (e.g., data management, core labs) Clinical Sites
WHAT & WHO ARE THE RESOURCES IN YOUR INTERNAL QUALITY ASSURANCE GROUP ?
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
Internal GCP Audits
Assessment of training files SOP review with gap analysisIn anticipation of a Sponsor audit by FDA
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
servicesAudits at other times
Routine, on-going basis Prior to interim and/or final analysis For cause….
External Audits – Clinical Sites
Mock Audits Prior to Final Database LockWhy Now?
Last opportunity to take a systematic look at the quality of the data
How?Quality Assurance department or CROAllow 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
5 Habits of Highly Effective Device Sponsors – CRO involvement
1. Establishing SOPs2. Hiring employees with experience
in conducting clinical studies3. Utilizing a consultant such as a
CRO for study functions beyond the sponsor's in-house capabilities
4. Conducting internal and external audits of the clinical study processes, procedures and personnel
5. Review of clinical study issues by management with executive responsibilities
1. YES with customization to your organization
2. Need core expertise in your organization to oversee and manage CROs
3. YES with careful selection of CRO and thoughtful decisions regarding which functions to outsource
4. YES especially when internal QA resources are limited or GMP/GLP focused
5. NO Must be a retained responsibility within your organization
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 needsCarefully select your CRO to match the needs of your
organization Alignment with values, priorities and needs
