Authorised by competent authority and certified according to DIN ISO 9001
Organisation of clinical studies
As Clinical Research Organisation (CRO) the Management and Investigators of Nova-Clin has been involved in organisation of more than 400 Phase I-IV studies.
Our services:
- Project/study management
- Study conception and planning
- Case Report Form (CRF) conception
- Informed Consent Form (ICF) conception
- Selection of Clinical Centers
- Medical Writing (Clinical Study Protocol, Clinical Study Report, Investigator Brochures)
- Clinical Trial Application (CTA)
- Data and Safety Monitoring Board (DSMB)
- Monitoring
- Site management
- Data management
- Statistical analysis
- Pharmacovigilance
- Medical Monitoring
Indications:
- Internal medicine
- Pulmonology
- Cardiology
- Oncology
- Gastroenterology
- Hepatology
- Rheumatology
- Allergology
- Hematology
- Vaccines
- Psychiatry
- Surgery
- Urology
- Infectious disease
- Dermatology
- Orthopedy
- Endocrinology
- ENT
- Ophthalmology
- Gynaecology
Conduct of clinical studies
As Clinical Research Unit (CRU) the Management and Investigators of Nova-Clin has been conducted more than 50 Phase I-IV studies.
Our services:
Clinical conduct of Phase I studies in healthy subjects, special population (children, elderly) or patients:
- Proof of concept
- First in human
- Dose escalation
- Food/Drug interaction
- Drug/Drug interaction
- Mass balance
- BA-/BE studies
- Studies for food supplements
- Studies for medical devices
Clinical conduct of studies in patients:
- Phase II/III
- Authorised indications: Pneumology, Cardiology, Internal Medicine
Specific services and experience (examples):
- Vaccines
- Special diets
- Monoclonal antibodies
- Recombinant factor IX and VII
- TNF α
- α adrenergic
- Oral/IV/IM/Topic/Intra-bladder drug administration
- prolonged hospitalization (up to 29 days)
- intense PK sampling
- blood/urine/faeces sampling
- multiple ambulatory visits
Factsheet / You can download a summary of our companies here.
Nova-Clin Medical Research Center S.R.L.
Rigoletto 14, 300696 Timisoara, Romania
+40 726 160181 I office@nova-clin.com
Competent Authority approved and certified according DIN ISO 9001
In cooperation with our partner companies ACC and DELPH-i as well as our network, we complete and fulfil your needs for successful product development, marketing authorisation and batch certification. Visit our partner websites:
