Drug and Device Development Opportunities

Responsible Conduct for Research: Roles, Responsibilities, and Strategies for Success

Indemnification: Contract Language Risks

The Right to Know: Informed Consent and HIPAA Regulations

Protection of Human Subjects: IRBs and Their Impact on Research

Vital Information for Research Sites: Surviving IRB, FDA, and Sponsor Audits

Good Clinical Practices (GCPs): Impact on the role of a CRC

Phase I, II, III, and IV Study Highlights

Roles and Responsibilities of the Coordinator, Principal Investigator, Sponsor, and Monitors

Understanding Basic Regulatory Requirements

Confidentiality and Privacy Issues: Protecting Human Subjects

The Informed Consent Process

Source Documentation Practices that Will Survive Any Audit

Adverse Events: Expected, Unexpected, Serious, Reportable?

Organization of Protocols and Subject Information

Drug/Device Accountability: How to Prevent Mistakes

Recruitment Strategies that Work

Research Pitfalls and How to Avoid Them

Protecting Human Subjects: The Privacy Laws as They Relate to Research

Informed Consent: What it Means to the Subject, the Researcher, the Sponsor, and the IRB

Regulatory Issues: Understanding International, Federal, State, and Local Laws and Guidelines

Working with IRBs and Ethics Committees

Standard Operating Procedures

Conducting Internal Quality Assurance

Patient Recruitment and Retention

Organizational Strategies for Strong Research Programs

The Budget Process: Negotiating Contracts, Calculating Clinic Costs, Covering Costs

Communication for an Effective Research Program

Training for Continued Site Improvement

Expansion Tips for Growing a Research Program

The most successful research businesses are those that use the proper strategies and tools to analyze, develop, verify, record, and report, in intricate detail, every aspect of their financial management.

Participants will receive information on successful budgeting, contract evaluation and negotiation, staffing, marketing strategies and key regulatory/legal requirements and considerations. Tools to assist in the management of a site’s financial needs, including operational systems and information technology, will also be discussed. Emphasis will be placed on identifying hidden and unexpected protocol costs to enable your site to maximize its budget and profitability.

Real-life cases will be presented, and references to other authorities, books, and publications will be provided.

Combined with practical information and the experiences of the presenters, this course will emphasize the importance of building an integrated business team and will equip program participants with the tools necessary to build and manage a successful research business.