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Legal and informational support of the clinical trials

Clinical trials' feasibility

Study documents' development and preparation

Within agreed with Sponsor timelines we prepare:

- Study Protocol,
- Investigator's Brochure,
- Informed Consent Form and Patient Information Sheet,
- Case Report Form and other documents.

We provide high quality translation of documents into Russian/English.

Sites preparation to the clinical trials

- selection and evaluation of the investigational sites (we have wide experience of collaboration in clinical trials with more than 680 investigational sites in Russia),
- acting as a Site Management Organization (SMO) we propose INVITRO's own medical centers as a net of investigational sites,
- contracts execution with investigational sites and investigators,
- Investigator meetings preparation and conduction.

Regulatory support: preparation and submission of study documentation packages to Russian regulatory authorities, obtaining clinical study approvals, import and export licenses

Legal and information support of the study

Clinical trial logistics: study drug, materials and equipment import to Russia, storage, distribution to the investigational sites, destruction

Full complex of the Central laboratory services, transport of biosamples throughout Russia

- Laboratory INVITRO is certified under the standards ISO 15189 and ISO 9001,
- Laboratory Information System is implemented to raise the efficiency, simplify the quality control and monitor lab results on-line,
- More than 1000 tests menu,
- Development of the study-specific laboratory kits,
- State-of-the-art lab equipment from the leading manufactures (GCP, GLP)
- Highly qualified staff experienced in clinical studies and trained in ICH-GCP, IATA, GSP, GDP, GMP,
- Working schedule: 24 hours a day, 7 days a week without weekends,
- Own logistic service:

  • ~100 cars serve a zone in a radius of 500 km from Moscow what allows making quick delivery in time 24 hours.
  • 1-12 hours — delivery time across Moscow and Moscow region,
  • < 500 km from Moscow — transportation is made by air or the specialized motor transport,

- each delivery is tracked by personal coordinator,
- delivery "from hand to hand" at 5 guaranteed temperature modes: -70 °C (dry ice); -20 °C; +2+8 °C; +15+25 °C; +35+37 °C.
- on-line tracking of location and shipments' temperature, GPS, GSM modules,
- biomaterial sampling is made in all territory of Russia. More than 200000 biomaterial transportations with 1-24 hours delivery period were done in 2011.

Storage, including long-term, biological samples and study materials

- We use own INVITRO laboratory complex's rooms for biosamples' storage,
- 550 m2 - area of the central warehouse in Moscow.
- The certified refrigerating appliances and the debugged work of logistic team guarantee observations of all temperature conditions and safe storage during the time determined by the sponsor.

Project management

- project planning, coordination of terms with Sponsor,
- budget and contracts' negotiation with the Sponsor,
- coordination of project team's work,
- regular study status reports to Sponsor,
- observation of study of terms and study budget,
- control of study documents writing and maintenance.

Monitoring investigational sites

- Initiation visits,
- Monitoring visits, detailed visits' reports,
- Investigational Product accountability at the sites,
- shipment and analysis of biosamples,
- control of SAE reporting by the sites,
- control of ICH-GCP conducting by the investigators,
- Close-down visits;

Data management

- plan of the statistical analysis of data, sample size calculation,
- establishing trial's database,
- data entry services,
- queries' distribution and processing,
- statistical analysis of study data

Preparation and submission Clinical Study Reports to the Russian regulatory authorities