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

Further questions:

Kate Giovino

kgiovino@organo.com

781-401-1136