Workshop: Clinical Project Management

Event Organizer: GCP-Service International Ltd. [&] Co.KG
Venue: GCP-Service Training and Conference Center (Spain), in your office or other facilites
Date: By appointment
Number of participants: We require 6 participants or more at your venue in order to carry out this advanced training.

Workshop: Clinical Project Management

3.800,- Euro plus 19% sales tax

6-8 participants

4.200,- Euro plus 19% sales tax

9-12 participants

5.000,- Euro plus 19% sales tax

13-18 participants

6.500,- Euro plus 19% sales tax

more than 18 participants
Additional costs based on expenditures: Flight (Economy Class), Hotel (approx. 100 Euro), Car (0,55 Euro/KM). Cancellation of seminar participation until 15 business days prior to the appointed date without any costs, i.e. a processing fee will not be charged. If the cancelation is less than 15 busines days prior to the seminar the complete invoice will be charged. The same applies to non-attendance of one or more participants.

Contents and Objectives of the Course:

Project Management (PM) in Clinical Trials is a broad and often vague term. Many companies associate different tasks and responsibilities with PM. The definition of PM is  hereby often heavily influenced by the size of the company, whether it is a sponsor or a CRO, which kind of products are clinically tested, and many more. Training providers who offer advanced training for Project Managers and try to incorporate every single aspect in a single course, can at most only provide a very broad overview. In our point of view efficient Project Management courses should be adapted individually and should be practice-oriented.

It is therefore our aim to provide our customers with an advanced PM workshop that is strongly tailored to their specific needs, their prerequisites and their goals. In order to be able to deliver the best experience we   need a minimum lead time of 2 months for the preparation of each individual course. We will send out a short questionnaire prior to the workshop which will help us to individualize each workshop to fit our customers’ requirements.

Day 1

09:00-12:00

Basics of Clinical Research: What kinds of studies exist and what are their specifics?

– Drug approval
– CE certification
– Laws, Guidelines, Regulations
– Authorities and Notified Bodies

Tasks of the Clinical Project Manager

– Required skills of a Project Manager
– Classical duties of a Project Manager
– Individual duties of a Project Manager
– Links between duties of a Project Manager and duties of other departments
– Priority setting or 24/7 services?

12:00-13:00 Break
13:00-16:00

Pitfalls of a Clinical Trial: An immature study design

– Site selection
– Country selection
– Planning of inclusion and exclusion criteria
– Basic statistical concepts
– Different study designs
– Sample size calculation

Risk Based Project Management

– Risk based Monitoring: Trend or meaningful method to guarantee a successful study
– Definitions of terminology: Risk based Monitoring, Adaptive Monitoring, Remote Monitoring, Central Monitoring
– Risk management in theory and in practice
– Risk analysis: First step of risk assessment

Questions, Answers, Exchange of experiences

Day 2

09:00-12:00

Keeping Oversight

– Risk analysis: From analysis to control of risks
– Sources of risk identification
– Reporting of risks
– Minimizing risk
– Corrective and preventive action

12:00 – 13:00 Break
13:00 – 16:00

– Study Budgeting
– Budget control/time control
– Milestones
– Dealing with Out of Scope Costs
– Team Communication
– Communication between CRO and Sponsor
– Escalation
– Proactive handling of errors for continuous improvement

Questions, Answers, Exchange of experiences