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