Our services
Quality management
Based on a decade of experience with clinical quality services provided to external clients, Addomed can develop and follow a complete auditing programme as well as only particular auditing services.
Clinical system and procedure development
Addomed follows its ICH and EU Directive compatible SOPs but is able to operate also under the client’s Standard Operating Procedures (SOPs). QA system ensures that required quality level of tasks and results is attained during performance of clinical trials and other activities of the company. The basis is given in Quality Manual.
Clinical operation management
Working with different pharma companies and CROs (Actelion, KCR, BI, GSK, Jansen Cilag, Chiltern Sandoz (Lek)) and considering different monitoring strategies we are able to plan an intelligent and effective project specific concept which fits your needs.
Training
Training courses can be customised to suit individual client needs. Addomed is ready to share its long-term experience in clinical research either with the beginners in this area as well as with the experienced members of the trial teams.
WHY ADDOMED?
EXPERIENCED TEAM
The Addomed advantage begins with something essential: experience. We have the resources and experience to help you navigate the ethical, legal, and regulatory risks associated with complex, far-reaching studies, paired with the agility required to meet your study’s unique needs.
QUALITY SERVICE
The highest quality is our goal and the real challenge, which is why we put all the efforts to achieve results synonymous with professionalism. We continually set a high bar for ourselves in terms of requirements which results in manitaining very high standards of work.
FOCUS ON CLIENTS
We offer the experience of an international company with the tailored service of a local enterprise which adds a great value to your projects. Working side-by-side and sharing the risks is the only way to be a real partner.
Our clients
PHARMACEUTICAL COMPANIES
CROs
NON-PHARMA COMPANIES
CLINICAL RESEARCH SITES
What our clients say
I had the opportunity to directly collaborate with Addomed in several clinical projects over a period of 5 years and to be involved in joint projects for additional 4 years. Addomed has proven himself as a valuable and fully reliable collaborator for Medical Trial Analysis.
Addomed has performed and continues to perform as an Expert GCP Auditor on behalf of our pharmaceutical clients within Europe, and the Americas.
With Addomed strong clinical study management skills, Addomed was able to implement effective recruitment and retention strategies and come immediately with the suggestions how to ensure successful completion of all clinical activities within the required time frame and budget.
We have been fortunate to have Addomed support our CQA efforts by successfuly conducting site audits of Clinical Investigator Sites in the European Union
Our experience
We have experience from various audits performed for external clients for sites based in USA, UK, Europe (Norway, Belgium, Netherlands, Germany, Austria) different CEE countries (Russia, Croatia, Slovenia, Serbia, Macedonia). Beside sponsor’s trainings, our QA has been trained on ISO 9001 quality system and passed several Barqa and Brookwood Academy courses.
Addomed can help you cover your QA, monitoring and data management needs in the region of Central and South Eastern Europe.
Our services can be adapted to suit the size and scope of the project, as each project receives the same level of attention to detail and commitment in order to ensure the delivery of a high-quality outcome, within budget and within the agreed timescale.