Full Range of CRO Services

We offer full or modular services in pre-clinical & clinical drug development in phases I-IV, including project management, study sites & investigators selection and feasibility checks, translation of study documents to Russian language, obtaining Regulatory Authorities approval and central/local Ethics Committee votes, study medication importation, investigators training and start-up meetings organization, study monitoring according to our own or sponsors SOPs with permanent quality control and regular reporting to sponsor.

 

 

 
     

Study sites selection

Study sites and investigators selection using extensive own database

   
     

Regulatory Authorities approvals and ECs vote

Applications to Authorities and ECs and obtaining permissions and votes in a short time

   
     

Study medication and study related equipment

Customs clearance, storage, delivery, accountability, destruction of study medications and study related documents and equipment 

   
     

Transportation of laboratory samples

Delivery of laboratory samples and specimens from different parts of Russia to central laboratories in other countries

   
     

Project management and study monitoring

Professional project management and GCP monitoring

   
     

Investigator’s and monitor’s training

GCP training for investigators, study staff and monitors

   
     

Audit

Preparation of investigators to GCP audits and inspections, assistance to auditors

   
     

Registration of medications in Russian Federation

Support at all phases of medication registration process

   
  Яндекс.Метрика
    
 

Visits to Russia

Organization of foreigners’ visits to Russia (visas, hotels, transportation) 

   
 

© JSC AMT, 2012