AKP

Study Management

A well designed and structured study concept

Intensive supervision and guidance of study participants assure compliance...

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Medical Writing

In close collaboration with the sponsor

We support you in developing a feasible study design...

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Regulatory Affairs

AKP´s regulatory support for Phase II – IV trials

We ensure that all regulatory activities are of highest quality...

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Regulatory Affairs

AKP is able to provide regulatory support for Phase II – IV trials, non-interventional and Medical Device studies.

We ensure that all regulatory activities are of highest quality and compliant with the national regulations.

Our services include but are not limited to:

  • Consultancy regarding study design, clinical development planning and submission requirements
  • Medical Writing and / or document reviews: protocols, observational plans, amendments, patient’s information / Informed Consents, investigational product labels, etc.
  • Preparation and management of clinical trial applications to Regulatory Authorities
  • Programming of electronic Case Report Forms
  • Submission to Ethics Committees
  • End of study and outcome reporting


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Arbeitskreis Klinische Prüfungen
PD Dr. med. Seiler GmbH
Munzinger Str. 10
79111 Freiburg/Germany

phone:+49 761 479 40-0
fax:+49 761 479 40-22
mail: info@akp-freiburg.de