SERVICES

As required by Article 19 of the EU Clinical Trials Directive (Directive 2001/20/EC), if the Sponsor does not have an office or registered address in the EU and they wish to perform clinical trials in the EU they must have a legal representative who is established within the European Union.

This provision is mandatory and without a Legal Representative the clinical trial will not be approved by the Regulatory or Ethics authorities.

The Legal Representative may be an individual person or a representative of a corporate entity, should be willing to act as the agent of the sponsor in the event of any legal proceedings instituted in the European Economic Area (EEA), e.g. for service of legal documents, and should be established and contactable at an address in the EEA;

We have 5-year expertise in representing non-EU Sponsors (from U.S., Canada, Israel) and our legal representative services will be provided to you by experienced staff, trained in clinical trial processes and legislation, and in the EU regulatory environment.

Sponsors want their new products validated by clinical trials. Patients want quick access to new medicines. Since Start-up one of the most complex and heavily regulated parts of any clinical trial, involving clinical sites, Competent Authorities (CA), Ethics Committees (EC), vendors etc., you will want for this step of the trial someone to provide you not just with regulatory expertise, but also with clear communication and effective planning.

We cover all aspects of Start-up and Regulatory operations, including CA and EC submissions, sites and other vendors (labs, depots etc.) contract negotiation, and the corresponding oversight of those activities.

Our services will be provided by regulatory specialists with more than 10 years experience in the field, and who will guide and assist you with the preparation of the applications, handling of the submission process and liaising with regulatory bodies in order to obtain regulatory approval.

We have extensive experience with the start-up/regulatory process, not only in EU countries (such as Romania, Bulgaria, Croatia, Poland) but also in other East and Central European countries (including Serbia, Bosnia, Moldova)

1. Dedicated Site Project Managers (SPM) and Local Site Project Managers (LSPM)

• Only one point of contact and a single information provider for your project
• Coordinating the Site Research Coordinators (SRC)

2. Global coverage

• SMO has access to a huge network of investigators/specialists to manage your multi-centric clinical trials in different therapeutic areas
• top investigators and a database of over 150,000 patients in Eastern Europe.
• direct access to naive patients if so required
• accelerating patient enrollment and effectively managing the trial from start to finish

3. Dedicated, highly qualified well trained site research coordinators as part of sites teams

• site research coordinator with training in ICH –GCP
• site research coordinator with training in various therapeutic areas

4. In-depth and fast project feasibility

• we help our clients in planning ahead and formulating realistic forecasts and – to have a real view and obtain a realistic timeline and budget for their clinical trial

5. Fast obtaining of documents for feasibility and regulatory submissions

• site documents requested for feasibilities – CDAs and Feasibilities Questionnaires
• site documents requested for submission – CVs, GCP certificates, Manager approvals etc

6. Site preparation for the clinical trial

• Materials ready
• Preparation of list with potential patients

7. Additional help for managing the study

1. Dedicated the Site Research Coordinators (SRC)

• SRC is part of day to day activities at your site/hospital and will be the liaison between site and CRO

2. Increasing scientific image of the hospital and doctors

• Possibility of scientific publication about the clinical studies
• Participation at international meetings

3. Increasing income with new studies

• Including the site in a huge data base
• Participation to all feasibility without any cost

4. Minimize of negotiation time with CRO/Sponsor

• Negotiation of budgets and contracts with the CROs/Sponsors for the new studies using the own templates or implements the main directions agreed by site in all contracts and budgets received from Sponsors/CROs

5. Faster preparation of submission package (paper preparation)

6. Maintenance of site Investigator File

• files and logs updating on daily basis to be ready for inspection any time

7. Administrative activities

8. Develop of site SOP for clinical trail (own site logs and forms)

9. Development of site specific documents (study specific SD templates study)

10. Increasing number of patients by referrals from other hospitals/doctors

• SMO will use the own data base to refer patients to the qualified sites

11. Faster reporting of clinical data

• The SRC will be trained to enter the data in data base
• The SRC will help the teams to manage the study