CRO Services

• Development and maintenance of study plan and timelines
• Communicating study expectations to team members
• Provision of study-specific training for CRAs
• Study budget preparation
• Preparation of meetings with agendas and minutes
• Preparation of enrollment notification and updates, site newsletters, study updates, protocol deviations, etc.

• On-site personnel training
• On-site monitoring (pre-study, initiation, interim and close-out visits)
• In-house site management, CRF review
• Regulatory documents collection and review
• Monitoring of regulatory status of studies on sites
• Management of information collection from Investigational site
• Monitoring reports completion
• Query resolution
• Participation in Investigators meetings

• SAE training of clinical personnel
• Creation of study-specific SAE reporting Standard Operating Procedures
• SAE reporting and Sponsor notifications (24 hours 7 days a week)
• Preparation and submission of SAE reports to Regulatory Authorities, Investigators, and to local Ethics Committees
• Generation of SAE narratives and follow-up reports, translation of medical records

• Receiving, storage, and distribution of clinical trials supplies
• Obtaining of Import/Export Licenses from local Regulatory Authorities
• Import of study drugs from Western Europe and USA
• Export of biological media
• Frozen and refrigerated batch shipments of biological specimens to laboratories in Europe, Canada, USA
• Short to long-term specimen storage
• Custom clearance (including pro-forma invoice creation and shipment documents review)

• Evaluation of Standard Operating Procedures and Study Specific Procedures for their consistency with International Quality Standards for designing, conducting, recording, and reporting clinical trials (ICH guidelines)
• Assistance to Functional Managers in the development of Standard Operating Procedures
• Approval of all Standard Operating Procedures and monitoring of the development, approval, periodic review, revision, version control, and historical archival of all Standard Operating Procedures
• Conducting of Internal Audits to ensure that operation of all Functional Groups is in compliance with the internal Standard Operating Procedures
• Overseeing external auditing or vendor qualification function (per Sponsor request)
• Preparations for inspections by Sponsor and Regulatory Authorities
• Representation of Sponsor in interactions with external organizations including Regulatory Authorities, Clinical Trial sites, and other organizations
• Serving as a primary contact during all audits
• Generation of responses to audit reports

• Regulatory submission for approval of Russian Ministry of Health
• Regulatory submission for approval of Pharmacology Committee and National Ethics Committee
• Obtaining of Import/Export Licenses
• Expedited Study Approvals
• Local Insurance policies for patients