Services

Servicesexperience

Study feasibility

GMS performs a full Site/Investigator feasibility analysis in Poland and CEE with reference to requirements of proposed clinical study. We recommend investigators who are experienced in conducting clinical trials. The investigators are some whom we know from our own experience or who have been recommended by cordial CROs or Sponsors. The sites which have been recommended by us have all the requested equipment, facilities and resources to complete the study from start to finish. This ensures the high recruitment of eligible patients.

Study insurance policy negotiations

We are able to recommend insurance companies offering the most cost effective insurance products for clinical trials in Poland. We have also expertise in negotiating on behalf of Sponsor of type and cost of insurance policy (depending on requirements of clinical trial).

Site/Investigator contracts negotiations

We provide templates of each type of contract and we are able to negotiate all the terms and conditions with Investigators and Site attorneys to reach a consensus within a reasonable time frame.

Regulatory services

We offer the preparation of the complete clinical trial documentation applicable for submissions to Regulatory Authorities and Ethics Committees. Our staff have a long track record in dealing with Authorities. This ensures the GMS team is able to complete the study regulatory process as soon and as effectively as possible.

 

Monitoring and management of clinical studies phase I-IV and observational/registry projects

GMS offers experienced Clinical Research Associates and Project Managers based in Poland who are able to perform on-site and in-house monitoring as well as management services in phase I–IV clinical trials. Monitoring and management services can be conducted according to SOPs of GMS or/and SOPs of our Clients, depending on their requirements.

Our monitoring activities are:

  • Pre-study (Qualification) visits
  • Site Initiation visits
  • Interim Monitoring visits
  • Close-out visits and
  • Source Document Verification
  • Clinical Study documentation handling
  • Reporting of safety related information
  • Administrative and financial tasks (e.g. investigator, clinic or hospital payments)

Market analysis and strategic planning

  • Market opportunity analysis
  • Medical and econimical analysis
  • assistance in HTA preparations and submission
  • Regulatory support for new products and technologies
  • Set up marketing strategy

Pharmacovigilance

  • safety reporting
  • case management
  • literature surveillance
  • PSUR writing
  • DDPS and RMP writing
  • eReporting to EudraVigilance by means of EVWeb tool
  • serve as a pharmacovigilance contact in Poland
  • Medical Monitoring