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Clinical Trials, Knowledge Management & Statistics

The Clinical Trials, Knowledge Management & Statistics Management course covers the practical management of the development of a medicine from Phase I to IV using the latest agile and adaptive research techniques to optimise efficiency in the development process. It also teaches students how to critically review and evaluate statistical data and leverage the information and knowledge created to contribute to the competitive advantage of their organisation. This is a practical course on how to plan and manage clinical trials cognisant of the pharmacoeconomic conditions and leadership challenges that students need to address, when leading clinical development programs.

More information

After successfully completing this course, students will be able to:

 -Critically appraise the principle steps in the clinical trial phases that can often be based on incomplete and sometimes contradictory data and objectives

-Evaluate the suitability of research methodologies for the purpose of undertaking clinical trials as adaptive as possible

-Critically review the issues (including legal, ethical, clinical and/or commercial) involved when undertaking clinical trials

-Demonstrate the ability to plan and develop clinical trials in accordance with legislative requirements and Good Clinical Practice (GCP) procedures

-Critically interpret and manage statistical data used in clinical development and discriminate between relevant and non-relevant data and be able to justify such decisions


Topics

• Induction - Clinical Trial Management

• Fundamentals of Statistics

• Project Planning and Management

• Clinical Development Plans and Study Design

• Trial Design, Hypothesis Testing and Power

• Conducting a Clinical Trial

• Measurement and Types of Data

• Working with External Partners

• Types of Analysis

• Interpretation of Study Design, Analysis and Results

• Quality Systems, Submissions and Inspections

• Research Methods for Clinical and Epidemiological Research

• Agile Development Techniques

• Bayesian and Frequentist Perspectives on Research

• The study Protocol

• Statistical Computing I

• Statistical Computing II

• Random Sampling and Randomisation

• Knowledge Management

• Practical Considerations in the Daily Operations and Management of a Clinical Research Sit

Contact | Information material

For further information about our in-house seminars, company terms and conditions or questions regarding our content please get in touch with us via email, phone or the contact form. We would also be pleased to send you our 'Offers for companies' information brochure. We look forward to hearing from you.

Merlet Behncke-Braunbeck
Director Distance Learning
Tel.:  +49 (0) 6221 487 8061
E-mail: merlet.Braunbeck@springer.com.

Please contact me directly or use the quick & easy
Contact form for corporate customers



Date | Price | Audience


Course: 

Self-guided learning


Co-operation partner: 

Healthcare Learning


Duration | Workload | Certificate: 

8 weeks | 60 hours of tutor guided learning activities | Certificate of completion by Healthcare Learning


Level:

Postgraduate


Price:

€ 2.000,- (plus VAT)


Start:

Rolling


Booking:

Companies can book this course for their employees directly at Springer Campus. If you are an employee of a company and would like to take this course, please contact your HR department so that they can book the course for you at Springer Campus. 


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