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: [email protected]
T: +48 22 613 34 07
F: +48 25 740 79 25

Australia

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