DUBLIN–(BUSINESS WIRE)–The “CROs (Clinical Research Organizations) – Identification, Selection, and Management for Maximum Results & Value” training has been added to ResearchAndMarkets.com’s offering.
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 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.
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 Should Attend:
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
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.
Key Topics Covered:
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…