"Nothing Happens by Itself"

Global Medical Services Poland

We are a privately held Contract Research Organization founded in 2008 by a team of professionals with significant experience across the entire clinical research sector in the EU, the USA, and other countries.

Services

We offer the following tailored services either as a separate partner or an integrated member of your organization:


  • Feasibility of national and international clinical trials incl. Australia
  • Development of study design and study protocol
  • Preparation of all study related documents
  • Study sites selection
  • Contract and budget negotiations with sites
  • Insurance for all EU member states

Study Start-up

  • Preparation and Submission of CTA to Competent Authorities (CA) and Ethics Committees (EC)
  • Ongoing communication with CA and EC
  • Preparation and Submission of SA to CA and EC
  • Submission of DSUR to CA and EC
  • Submission of the clinical study report to CA and EC
  • MAH services for the EU

Regulatory Affairs

  • Project management
  • Site and Vendor management
  • Subject recruitment support
  • On site and remote monitoring
  • Pharmacovigilance and Drug Safety
  • Medical monitoring

Study Conduct

  • EMA registration of a new entity
  • Acting as EU QPPV in EEA
  • Registration of QPPV in EudraVigilance
  • Registration of PSMF location in EV
  • Provision of a national contact person for PV
  • Preparation of EU PSMF and PV operating procedures

PV Services

  • Data Management Plan
  • Data Cleaning Plan
  • eCRF/CRF design, database development and validation
  • Data processing (entering – including double data entry, cleaning, transforming)
  • Query management
  • MedDRA coding

Data Management

  • GMS offers LR Services according to Article 74 of the EU Clinical Trial Regulation (CTR) to ensure that international Sponsors without a registered affiliate in any of the EU member states fulfill their Legal requirements as the European Representation, which is essential for the purpose of conducting clinical research projects in the EU

EU Legal
Representation


About Us

We combine our past experience of working in global contract research organizations with the expertise of physicians and investigators with solid backgrounds in leading research and medical centers.

Our reputation is based on competence, commitment, and effective client-oriented cooperation.

We provide a full range of clinical development services for various entities:

  • Pharmaceutical and medical device industries
  • Biotechnology and CRO companies
  • Academic sites
  • and other healthcare institutions.

We offer comprehensive services in planning, managing, monitoring, and reporting during all phases of clinical trials.

Our team provides expertise in regulatory affairs, research governance, and Good Clinical Practice in conducting clinical trials in the public health system as well as in commercial and academic sites.

Why Global Medical Services?

  • Strategic access to a network of physicians, suitable sites, and patients within disciplines important to our clients
  • Experienced monitors and PM professionals together with Regulatory and PV certified specialists allow us to effectively manage our clients’ clinical programs
  • High quality study execution within realistic schedules, budgets and contract terms

Contact

Poland

BEREZYŃSKA STR. 39 OFFICE 38
03-908 WARSZAWA
Email: office@gmspolska.com
T: +48 22 613 34 07
F: +48 25 740 79 25

Australia

SUITE 10, 51 DARLING POINT RD.
NSW 2027 SYDNEY
914