An ever-present issue for sponsor companies is whether to partner with a Clinical Research Organization. From that follows questions and strategies on how to best select a CRO and manage the relationship. The process takes on added dimension when conducting research internationally.
In this presentation, the speaker highlights key contract and relationship issues and the recurrent problems that arise within these relationships, and also offer practical, experience-based tips for maximizing the relationship's value and efficiencies. We discuss the difference between partner and vendor, and contract versus relationship. The presentation also examines local vs. U.S.-based CROs, and how to assess a CRO's experience and ability to comply with local rules and regulations and FDA requirements, as well as cooperating with the sponsor and other participating CROs.
This audio conference covers:
- The limits and potential of the CRO contracting process
- Recurrent problems and tips on handling them
- EU Legal Representative requirements and "Australian entity" requirements
- Using one global CRO vs. a combination of local CROs
- How and why compliance issues don't end at the U.S. borders
- Practical issues such as time zones, language, currency, local insurance and indemnification requirements, and whether the sponsor or CRO should hold the contract with the OUS site
About the speaker:
Maria D. Buckley is Of Counsel and a member of the Healthcare and Life Sciences practice groups with the Boston-based law firm Nutter, McClennen & Fish. Maria has an extensive background in healthcare law, health insurance, and managed care, with particular emphasis on contracts, reimbursement, and regulatory interpretation and compliance. Her clients have included hospitals, physician practices, ancillary services providers, HMOs, and medical device, pharmaceutical and biotech companies.
She helps companies, institutions and investigators document the clinical trials process. She also regularly provides compliance advice and training with respect to pharmaceutical sales and marketing activities, and frequently speaks on various healthcare and research issues. She has been active in providing pro bono legal service and is a recipient of the Massachusetts Bar Association's Pro Bono for Law Firms Award. Maria received a J.D. degree from Suffolk University Law School, and a B.S. from Boston University. She is an active member of the Health Law Section of the Boston Bar Association.
Who should attend?
- Attorneys
- Regulatory Affairs
- Clinical
- Medical Officers
- Scientific Officers
- Business Development
- Decision-makers in clinical research operations for a pharmaceutical or biopharmaceutical company
- CRO Senior Management and Business Development
This audio conference is rated General Interest.