CRO (Clinical Research Organizations) Training Course: Identifying, Selecting, and Managing for Maximum Results and Value (December 1-2, 2022) – ResearchAndMarkets.com

0

DUBLIN–(BUSINESS WIRE)–The training “CROs (Clinical Research Organizations) – Identification, Selection, and Management for Maximum Results & Value” has been added to from ResearchAndMarkets.com offer.

This CRO training provides all the specific management methodologies and techniques to successfully outsource pharmaceutical programs delivered on time, within budget, and most importantly delivered with a high level of quality and performance.

This course will provide participants with all the specific management methodologies and techniques to successfully outsource pharmaceutical programs, which are completed on time, within budget and, most importantly, with a high level of quality and performance.

Participants will gain an in-depth perspective focused on the components of performance-based management and quality of drug development. Participants will learn how current external and internal forces are shaping how projects will need to be delivered to be competitive and profitable given the state of the industry.

Particular attention will be given to defining meaningful Key Performance Indicators (KPIs), implementing these indicators into the process, and collecting/analyzing data to proactively deliver quality studies.

Pharmaceutical and biotechnology research managers and their CRO industry counterparts will gain a deep understanding of how to work together through the implementation of outsourcing dashboards to achieve successful outsourcing programs.

CRO management processes, including study plans, field visits, preparation for inspections, monitoring of assessment programs, progress and conditions for termination of a CRO’s services will be analyzed as well. as general data quality assurance requirements. Solutions to assessing and correcting issues involving all outsourcing projects as well as legal requirements of sponsors and CROs will be discussed.

Learning objectives

Ultimately, the challenge facing pharmaceutical companies today is to pursue two seemingly incompatible goals; maintain or increase product quality, while significantly reducing development costs and times.

With these general objectives in mind, participants will learn all the material necessary to identify and select the right CRO for each segment of the search targeted for outsourcing. Pharmacy staff will learn the techniques required to successfully manage CROs and the shared responsibilities required of sponsor and service provider. CRO staff will gain a full understanding of what is expected of them in the process of developing new drugs.

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 development process of their products for Regulatory Authority Approval. global health. Participants should have a basic knowledge of drug, device or biologic development processes and need to understand what is involved in outsourcing non-clinical and clinical research to CROs.

  • Vice-presidents, directors and managers involved in the management and selection of CROs

  • Administration and management of CROs involved in business development and operations

  • Project and program managers

  • Product Development, R&D and Engineering Managers

  • Quality Assurance Risk Manager

  • Regulatory Compliance Officers

The following questions will be addressed:

  • Type and selection of CROs (e.g. mega CROs, niche providers, etc.).

  • How the FDA and other health authorities view CROs.

  • Sponsor Responsibilities.

  • Drug development plans.

  • Global outsourcing programs.

  • Study specific designs and responsibilities.

  • Evaluation of the proposal.

  • Site visits to CROs.

  • Contract negotiations and partnerships with CROs.

  • FDA and EMEA (Europe) based interactions with CROs.

  • Write the RFP

  • Evaluation of RFP Responses

  • Supplier pre-qualification and supplier audits

  • CRO management

Participants will understand

  • The pitfalls of current sponsor/CRO/site relationships and what can be done to overcome them.

  • The new “Pharma” and the realities of “Virtual Trials”.

  • Components of the architecture of the appropriate “Cost vs Price” outsourcing model.

  • Determine core capabilities based on what works best globally rather than locally.

Main topics covered:

Program of day 1

Introduction to clinical research organizations.

  • Types of CROs

  • Duties expected 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 dashboard”

  • Link outsourcing models and processes to financial and customer objectives

  • Develop goals and metrics to evaluate outsourcing solutions

  • Use the dashboard as a communication and management tool

  • Use the dashboard to determine core capabilities/processes against outsourcing opportunities, as well as the skills and technologies needed to support an outsourced model.

  • Discovery and development plan.

  • Main milestones and deliverables

  • Quality and performance indicators

  • Responsibilities and Obligations of Sponsor.

CRO vendor selection process.

  • How to find a CRO

  • Selection criteria

  • Development of tenders

  • Ways to Compare and Contrast Before Selecting

Development Checklist and assessment “Heat Map” development.

  • General or project type information

  • Alignment with financial and customer objective

Site management and why it matters.

  • Review and evaluation of proposals

  • “Heat Map” Comparison Checklist

  • Contract negotiation and award

Agenda for day 2

CRO management.

  • Preparation, planning and positioning with CROs

  • Set up, planning and launch of the study

  • The KPIs you need to see and when you need to see them

  • Study medicine supplies

  • SOP: your business and your CRO.

  • Development of a study plan.

  • FDA / Health Authority and CRO legal requirements.

  • Collaborative tools and techniques.

  • Monitoring and evaluation of CRO methods and timelines

  • Clarity and communications with CROs

  • Realistic projections for projects, staff and CROs

Duties of CRO, sponsor and test sites.

  • Global knowledge: American and European regulations and nuances

  • How to ensure regulatory compliance, including:

  • GMP

  • GCP

  • GLP

  • Audit

Repair

  • Common problems and possible solutions

Main topics covered:

Kelly Thomas

vice president

Stallergenes Greer

Ms. Thomas has over two decades of hands-on cGMP industry experience in pharmaceutical and medical device manufacturing operations. His experience covers all Quality Systems; as well as all validation domains; including process/product validation, facility validation, CSV and 21 CFR Part 11, test method validation, automated equipment/processes and cleaning validation.

Using strategic thinking, risk-based approaches and Lean principles, she has demonstrated success leading and managing complex projects within the pharmaceutical and medical device industries.

For more information on this training visit https://www.researchandmarkets.com/r/izrf7g

Share.

About Author

Comments are closed.