AKP

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
  
  

Back