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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Medical Writing

In close collaboration with the sponsor we support you in developing a feasible study design through combining your ideas with our experience.

When planning clinical trials (AMG / MPG), IITs or NIS, clearly structured study documents are required right from the start to optimise the time for review and approval as well as to facilitate the implementation of the study procedures.

In cooperation with our sub-contractors we can offer the writing of the following study documents:

  • Protocols, including synopses and amendments
  • Observational plans
  • Submission documents to national authorities and Ethics Committees
  • Patient information sheets / Informed Consent Forms
  • (Electronic) Case Report Forms / (e-)CRFs
  • Patient diaries
  • Study manuals (laboratory, investigators, monitoring)
  • Newsletters
  • Clinical Study Reports (CSRs)
  • Training materials
  • Publications
  • Abstracts

Additionally we can support you in:

  • Professional literature research
  • Proof-reading of existing documents
  • Medical review of safety data


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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