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


  • 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

Competent Authority approved and certified according DIN ISO 9001

CA Authorisation
DIN ISO 9001 Certificate

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