Clinical Trials & Staffing
One of the oldest contract research organizations (CRO) founded in Romania, with over 25 years of experience in phase I to IV clinical trials and staffing services for pharmaceutical and medical device sponsors.
Presentation
Company presentation
Browse the presentation or download it as a PDF.
About our activity
Medical Research Monitoring Force is one of the oldest contract research organizations in Eastern Europe. The original organization was founded in Romania in May 1999, as a Romanian-German co-partnership. Other group companies followed, the most active being Medical Research Monitoring Force and Medical Research Group.
Managing Director and administrator of the Medical Research Monitoring Force companies in Eastern Europe: Alina Musetescu, MD, PhD.
We are the first company in Eastern Europe to perform phase I and II ICH-GCP clinical trials on medical devices (2000) and we actively supported the authorities in implementing the EU regulations for medical device clinical studies in Romania.
Services
- Project Management in ICH-GCP clinical trials
- All regulatory parts, from approvals to reporting to authorities and IRBs
- Audits
- Medical writing and medical reviewing
- Monitoring of clinical trials, phases I to IV
- Professional GCP training services for CRAs and investigators
- Staffing — ICTM, PM, CPL, CRAs, CPAs, RA, PhV
- Contract management of clinical trial sites and investigator teams
- Full services in phase I clinical trials
- Excellence in phase I trials in Diabetes, Nephrology, Cardiology and Oncology
- Fundamental research with the University of Medicine and Pharmacy, Bucharest
- Medical device clinical trials and registration
- Marketing of special medical devices in Rehabilitation, Dermatology, Radiology and Imaging
Therapeutic area experience
Diabetes & metabolic diseases
More than 40 clinical trials in diabetes and related metabolic diseases, including 11 in diabetes mellitus in children. Around 25 sites with high/medium recruiting potential across the country and another 20 in the region. Monitoring of more than 2,500 randomized patients. Experience in site training for specific procedures (glucometers, CGMS, electronic diaries).
Oncology
More than 25 clinical trials in oncology: hemato-oncology (lymphoma, multiple myeloma, lymphoblastic leukemia), prostate, breast, pancreatic, colon, ENT cancers, NSCLC/SCLC. Around 15 sites with high/medium potential in Romania and more than 15 in the region. Monitoring of 1,200/900 screened/randomized patients.
Neurology
17 clinical trials in neurology: Parkinson's disease, stroke and multiple sclerosis. Around 25 sites with high/medium potential across the region. Monitoring of more than 1,400 randomized patients. Launch and promotion of a patented medical device for patient recovery after stroke.
Cardiology
More than 20 clinical trials in cardiology: myocardial infarction and unstable angina, arterial hypertension and atrial fibrillation. Around 15 sites with high/medium potential in the country and another 10–12 in the region. Monitoring of 1,000/800 screened/randomized patients.
Medical devices
17 clinical trials on medical devices: cardiology (heart failure NYHA IV), orthopaedics (vertebral fracture, knee and hip prosthesis), nephrology (dialysis), intensive care (anaesthesia), immunology (HIV and oncology), allergy, depression and stress reduction. First company in Romania to run trials on stress reduction.
Recruitment examples
| Field | Indication | Phase | Rand. patients | Sites / comments |
|---|---|---|---|---|
| Oncology | NSCLC (1st line) | IIIa | 62 | 3 sites (Romania — best recruiter) |
| Oncology | Prostate cancer (2nd line) | IIIb | 98 | 6 sites (Romania — 2nd best recruiter) |
| Oncology | Multiple myeloma (2nd line) | III | 16 | 3 sites (Hungary) |
| Cardiology | Acute myocardial infarction — stenting | II | 121 | 4 sites |
| Cardiology | AMI & unstable angina non-STEMI — stenting | IIIa | 202 | 3 sites (Romania — 2nd best recruiter) |
| Diabetes | Diabetes mellitus in children | IIIb | 56 | 5 sites |
| Diabetes | Diabetes mellitus in children < 6 y. | IIa | 8 | 3 sites (Romania — best recruiter) |
| Diabetes | Diabetes mellitus in adults | IIIb | 870 | 20 sites (Romania — best recruiter) |
| Medical device | Heart failure (NYHA IV) | I | 24 | 2 sites |
| Medical device | Heart failure (NYHA IV) | IIa | 61 | 4 sites (Romania — best recruiter) |
| Medical device | Nephrology (dialysis) | I | 44 | 1 site (Rep. of Moldova) |
| Medical device | Knee prosthesis | IIa | 73 | 3 sites |
| Medical device | Vertebral fracture | IIa | 35 | 2 sites (Romania — best recruiter) |
Regulatory inspections & audits
Over the years, the company staff took part in numerous inspections and audits — with no major findings:
- 19 inspections from NMAMD (former National Medicines Agency, Romania) — no major findings
- 2 inspections from the BDA (Bulgarian Drug Agency) — no major findings
- 1 inspection from OGYI (Hungary) — no major findings
- 7 FDA inspections — no major findings
- 4 EMA (former EMEA) inspections — no major findings
- More than 30 sponsor-ordered audits — no major findings regarding the CRO/CRA activities
Quality assurance
Our Quality Assurance Department ensures a quality check and support for each CRA involved in a sponsor monitoring project, free of charge (only pass-through costs for the co-monitoring visits are invoiced).
ICH-GCP Training Programme
Our courses offer a flexible and cost-effective learning opportunity to develop GCP skills — for investigational staff and for CPLs, CRAs and CPAs:
- Basics of Good Clinical Practice (GCP) — emphasizing practical application
- ICH-GCP — advanced module
- Successful clinical research project management
- European, Romanian, Bulgarian, Hungarian and Moldavian legislation in clinical research
- How to deal with GCP inspections and audits
- Pharmacovigilance in clinical trials
- In-house courses tailored to the sponsor's requirements
Recognition
2010 — Top of Romanian Business Companies (LISTA FIRME, 1st District): position I for “Research-Development in Engineering and Natural Sciences”
2011 — Top of Romanian Business Companies (LISTA FIRME, 1st District): position I in the same category
2012 — Top of Romanian Business Companies (LISTA FIRME, 1st District): position I in the same category
Our main goal is to provide our partners with stability, loyalty and professionalism.