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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Study Management

Phase I – IV, non-interventional and Medical Device studies

A well designed and structured study concept, intensive supervision and guidance of study participants assure AKP's compliance with regulation and directives.

AKP also implements high quality standards of documentation and results – as evidenced by our outstanding audit evaluations.

AKP's intensive feedback communication keeps our clients well informed about the current stage of the project’s development.

 

Our services include:

  • Medical counselling in planning and realization of Phase II – IV trials and non-interventional studies
  • Project management: serves as your single point of contact, produces a detailed thorough project, communicates with all parties involved, creates a risk assessment plan, and leads and directs the project team
  • Feasibility analysis
  • Biometric planning
  • Study design
  • Development of all study related documents (e.g. study protocol / observational plan, paper based and / or electronic Case Report Forms (eCRFs), etc.)
  • Selection of study sites
  • Contract negotiations with study sites
  • Submissions and notifications to Ethics Committees (EC), Competent Authority (CA) and Local Authorities (LA)
  • Registration in public registers
  • GCP- and study-specific training for study personnel
  • Planning and conducting of investigator’s meeting
  • Patient recruitment support
  • Monitoring according to ICH-GCP / FDA and local regulations
  • Quality assurance for NIS on the basis of §67 sect. 6 AMG
  • Handling of investigator’s fees
  • Data Management
  • Statistical analysis
  • Medical Writing

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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