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
- 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
- Project management
- Site and Vendor management
- Subject recruitment support
- On site and remote monitoring
- Pharmacovigilance and Drug Safety
- Medical monitoring
- 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
- 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
- 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
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.
BEREZYŃSKA STR. 39 OFFICE 38
Email: [email protected]
T: +48 22 613 34 07
F: +48 25 740 79 25
SUITE 10, 51 DARLING POINT RD.
NSW 2027 SYDNEY