Clinical Research Organizations Course Description
This CRO training provide all the specific methodology and management techniques to successfully outsource pharmaceutical programs completed on time, within budget, most importantly completed with high level of quality and performance.
This course will provide the attendees with all the specific methodology and management techniques to successfully outsource pharmaceutical programs, that are completed on time, within budget, and most importantly completed with a high level of quality and performance. Participants will gain an in depth perspective focused on the components of performance and quality based management of drug development. Participants will learn how the current external and internal forces are shaping the way projects will need to be delivered to be competitive and cost efficient, given the state of the industry.
Specific attention will be given to defining meaningful Key Performance Indicators (KPI’s), implementing those indicators into the process, and gathering/analyzing data to proactively deliver quality studies.
Pharmaceutical and Biotechnology research managers and their counterparts in the CRO industry will gain a thorough understanding of how to work together through implementing outsourcing scorecards to achieve successful outsourcing programs. The following issues will be discussed:
- Type and selection of CROs (e.g. mega CROs, niche providers, etc.).
- How the FDA and other Healthcare Authorities view CROs.
- Sponsor responsibilities.
- Drug development plans.
- Overall outsourcing programs.
- Study specific designs and accountabilities.
- Proposal evaluation.
- Site visits to CROs.
- Contract negotiations and partnering with CROs.
- FDA and EMEA (Europe) based interactions with CROs.
- Writing the RFP
- Evaluating responses to the RFP
- Pre-Qualification of vendors and vendor audits
- Managing the CRO
Participants will understand
- The pitfalls of the current sponsor / CRO / site relationships and what can be done to overcome them.
- The new “Pharma” and the realities of “Virtual trials”.
- Components in architecting the appropriate outsourcing model “Cost vs. Price”.
- Determining core capabilities in accordance with what works best globally rather than locally.
The processes in managing CROs, including study plans, in-field site visits, preparation for inspections, monitoring evaluation programs, progress and conditions for terminating the services of a CRO will be analyzed along with the overall requirements of data quality assurance. Solutions to problem assessment and correction involving all outsourcing projects along with the legal requirements of sponsors and CROs will be discussed.
Day 1 Agenda
Introduction to Clinical Research Organizations.
- Types of CROs
- Expected Functions of a CRO
- Strategies used in Outsourcing
- The reality of "Paper and EDC" technologies what is really feasible?
Sponsor Action Plan "Setting the stage for success".
- The "Outsourcing Scorecard"
- Linking outsourcing models and processes to financial and customer objectives
- Developing objectives and measures to evaluate outsourcing solutions
- Using the scorecard as a communication and management tool
- Using the scorecard to determine core capabilities/processes vs. outsourcing opportunities along with the skills and technologies needed to support an outsourced model.
- Discovery and Development Plan.
- Key milestones and deliverables
- Quality and Performance indicators
- Sponsor Responsibilities and Accountabilities.
CRO Vendor Selection Process.
- How to Find a CRO
- Criteria for Selection
- RFP Development
- Ways to Compare and Contrast before You Select
Development Checklist and evaluation "Heat Map" development.
- General or Project - type Information
- Alignment to financial and customer objective
Site management and why it matters.
- Proposal Review and Evaluation
- Comparison Checklist "Heat Map"
- Contract Negotiation and Award
Day 2 Agenda
- Preparation, Planning and Positioning with CROs
- Study Set-up, planning and Initiation
- KPI's you need to see and when you need to see them
- Study Medication Supplies
- SOPs: Your Firm and CROs.
- Formulating a Study Plan.
- FDA / Healthcare Authority and Legal Requirements of CROs.
- Collaborative tools and techniques.
- Monitoring and Evaluating Methods and Timelines of CROs
- Clarity and Communications with CROs
- Realistic Projections For Projects, Staff and CROs
Duties of the CRO, Sponsor and Trial Sites.
- Global Knowledge: U.S. vs. EU Regulations and Nuances
- How to ensure compliance with regulations, including:
- Common Problems and Possible Solutions
Ultimately, the challenge facing pharmaceutical companies today is to pursue two seemingly incompatible goals; maintain or increase quality products, while dramatically reducing costs and development lead times.
With those overall goals in mind, participants will learn all the necessary material for identifying and selecting the right CRO for each segment of the research targeted for outsourcing. Pharmaceutical personnel will learn the techniques required for successfully managing CROs and the shared responsibilities required from the sponsor and the service provider. CRO personnel will gain the full understanding of what is expected of them, in the new drug development process.
Who will Benefit
This 2-day virtual workshop is designed for personnel in the Pharmaceutical, Biotechnology, Medical Device and Biologics industries who use Contract Research Organizations (CROs) in the process of developing their products for Healthcare Authority approval globally. Attendees should have a basic knowledge of drug, device or biologics development processes and a need to understand what is involved in outsourcing non-clinical and clinical research to CROs.
- VPs, Directors, and Managers involved in managing and selecting CROs
- CRO administration and management involved in business development and operation
- Project and Program Managers
- Product Development, R&D and Engineering Managers
- Quality Assurance Risk Management Manager
- Regulatory Compliance Managers
Kelly Thomas (25+ year exp.)
Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.