Service list

Ми надаємо послуги в Україні, Молдові, Грузії, Польщі, Румунії, Болгарії, Великій Британії, Туреччині, Казахстані, Узбекистані та балканських країнах

Study Materials Development & Review

  • Review of Sponsor-provided drafts of Clinical Study Protocol, other Clinical Study related documentation and creation of feedback with suggestions and recommendations which will facilitate the conduct of Clinical Study

  • Review of Clinical Study related documentation and its adaptation to country and/or site-specific requirements (documentation include but is not limited to: Patient Informed Consent Form, Patient Emergency Card, Patient Questionnaires & Diaries, Investigational Medicinal Product Labels). This service can be done for initial versions provided by Sponsor as well as for revised versions following Clinical Study Protocol Amendments and changes

  • Development of specific forms for use in Clinical Study (e.g., study logs, subject reimbursement forms, study newsletters, various instructions & guidelines)

  • Development of Clinical Project Plans (e.g., Project Management Plan, Communication Plan, Clinical Monitoring Plan, Trial Master File Management Plan, Third Party Vendor Management Plan etc.)

  • Review of Sponsor-provided drafts of Clinical Project Plans and their adaptation to country and/or site-specific requirements

Study Documents Translations

  • Translation of all types of Clinical Study related documentation by CRG in-house ISO 17100:2015 certified Language Services Department

  • Multiple language translation pairs are available that are in the highest demand in clinical research field

  • Each translation project involves Translation Project Manager, Translator, Reviewer and Subject Matter Expert Reviewer

  • Costs are based on language pair, per source word count (based on the SDL Trados Studio 2019 software) and per hour estimates

  • Translation memory is being used so every next translation for the same Sponsor will have reduced costs

Organization of Clinical Study Meetings

  • Conduct of Investigator Meeting and other types of Meetings for Clinical Trial Sites (both face-to-face and remote): venue selection, travel and catering, creation and printing of meeting materials, translations and interpreting, reimbursement of expenses

  • Support of Sponsor organized Investigator Meeting and other types of Meetings for Clinical Trial Sites (both face-to-face and remote): follow-up with participating Clinical Trial Sites, issue escalation and resolution

  • Conduct or support in organization of Clinical Study Project Kick-off Meetings (both External and Internal)

  • Effective organization of Clinical Study Project handover activities in case of business need

Regulatory
Послуги

  • Analyze and prepare regulatory country “landscape” (intelligence) for the conduct of Clinical Studies

  • Support the Sponsor in establishing regulatory strategy for Clinical Studies

  • Review, prepare dossiers and perform initial submissions to Regulatory Authorities, Central Ethics Committee, Institutional Review Boards/Independent Ethics Committees, and other regulatory bodies with the purpose of obtaining approval to conduct Clinical Study. Service also includes responding to potential deficiency letters received from authorities and ethics committees

  • Review, prepare dossiers and perform submissions to Regulatory Authorities, Central Ethics Committee, Institutional Review Boards/Independent Ethics Committees, and other regulatory bodies with the purpose of obtaining approval of substantial amendment(s) for Clinical Study. Service also includes responding to potential deficiency letters received from authorities and ethics committees

  • Prepare and perform all types of notifications to Regulatory Authorities, Central Ethics Committee, Institutional Review Boards/Independent Ethics Committees, and other regulatory bodies during the conduct of Clinical Trial (e.g., First Subject In/Start of the Clinical Study, periodic Clinical Study status reporting, End of Study notification, Clinical Study Report notification etc.)

  • Administration and processing of payments to applicable Regulatory Authorities, Central Ethics Committee, Institutional Review Boards/Independent Ethics Committees, and other regulatory bodies for their expertise of submitted Clinical Study Documentation

  • Obtain country-specific Clinical Study insurance for participating Subjects

  • Review of Sponsor-provided global Clinical Study insurance for participating Subjects and its adaptation to country specific requirements

  • Ongoing communication (where necessary) with Regulatory Authorities, Central Ethics Committee, Institutional Review Boards/Independent Ethics Committees, and other regulatory bodies during the conduct of Clinical Trial

  • Report Serious Breaches of Good Clinical Practice or the Clinical Study Protocol to Regulatory Authorities, Central Ethics Committee, Institutional Review Boards/Independent Ethics Committees, and other regulatory bodies as required

Clinical Study
Feasibility

  • Perform Investigator identification per particular Clinical Study using own large database

  • Distribute and fully execute Confidentiality (Non-disclosure) Agreements with identified Investigators

  • Develop feasibility materials to assess the possibility of potential Clinical Study Sites to take part in a particular Clinical Study

  • Review Sponsor-provided feasibility materials and create feedback with suggestions and recommendations which will facilitate the Investigator selection process in a particular Clinical Study

  • Perform Pre-Study Site Selection Visits (face-to-face or remote) to ensure that: 1) a potential Principal Investigator is qualified and interested in conducting the Clinical Study; 2) the Clinical Study Site has adequate facilities, and resources to properly complete all required study activities; 3) the Clinical Study Site has a required pool of subjects to complete enrollment. Each Pre-Study Site Selection Visit is carefully planned, conducted, reviewed and reported in written respecting the agreed with Sponsor timelines/requirements

Site Management & Monitoring

  • Distribution of Clinical Study Documents to Sites, collection of Investigator/Site regulatory documents for necessary submissions. Communications with participating Sites, enrollment planning

  • Negotiation of Clinical Trial Agreements with Sites (both on CRG or Sponsor template), their full execution (signing) and follow-up of any required actions

  • Setup of Clinical Study Sites and organization of all related Clinical Study logistics

  • Local purchase of Equipment/Materials necessary for Clinical Study conduct or support of Sponsor in this activity (if they supply it)

  • Executing the proper release procedure for the initial Investigational Medicinal Product/Medical Device shipment to Clinical Study Sites

  • Support the Clinical Study Sites in attending and completing of all required trainings necessary for Site activation. Perform necessary trainings for Clinical Study Sites as required

  • Preparation of initial shipment and distribution of necessary study supplies/documentation (e.g., Investigator Site File, Pharmacy File, blank templates of Informed Consent Forms, Patient Emergency Cards, Patient Diaries, paper Case Report Forms, equipment/materials etc.) to Clinical Study Sites
  • Perform Site Initiation Visits (face-to-face or remote) to ensure that: 1) the Principal Investigator and the Site Staff are familiar with the relevant study documentation, procedures and responsibilities as outlined in applicable regulations, Sponsor requirements prior to subject informed consenting and the conduct of any screening activities; 2) the Principal Investigator and the Site Staff are familiar with Investigational Medicinal Product/Medical Device and administrative procedures; 3) the Clinical Trial Site has adequate facilities and resources to properly complete all required study activities. Each Site Initiation Visit is carefully planned, conducted, reviewed and reported in written respecting the agreed with Sponsor timelines/requirements

  • Perform Interim Monitoring Visits (face-to-face or remote) to verify that (non-exhaustive list): 1) the rights and well-being of human subjects are protected; 2) the reported Clinical Trial data are accurate, complete, and verifiable from source documents; 3) conduct of the Clinical Study is in compliance with the approved protocol and amendments and with the ICH GCP guidelines, ISO 14155, US Food and Drug Administration and European Medical Agency regulations, and applicable local regulations; 4) the Site Team is meeting the timelines for subject enrollment, Case Report Form completion and Data Clarification Form /query resolution; 5) facilities and Site Staff remain acceptable for the conduct of the Clinical Study. Each Interim Monitoring Visit is carefully planned, conducted, reviewed and reported in written respecting the agreed with Sponsor timelines/requirements

  • Setup and maintain the study blind for applicable Clinical Studies – those in which neither the study subject nor the most of Contract Research Organization, Sponsor or Clinical Study Site staff, involved in the treatment or clinical evaluation of the study subjects, are aware of the subject treatment received (either an active drug or placebo or comparator)

  • Ongoing communication with Clinical Study Sites and issue resolution. Topics discussed include, but are not limited to: subject enrollment, Protocol related inquiries, opened action items, safety events and their management, Clinical Study equipment, materials, supplies and documentation

  • Documenting, tracking, escalation, and resolution of Action Item(s) for Clinical Study Sites

  • Management of Clinical Study changes at both Study and Site levels following the issuance of Clinical Study Protocol Amendments and other related changes

  • Support of Sponsor and Clinical Study Sites in safety events management (e.g., reporting of serious adverse events, events of special interest etc.). Ensure that all regulatory reporting requirements for occurred safety events are met

  • Support of Sponsor and Clinical Study Sites in management of Urgent Safety Measures in a particular Clinical Study

  • Re-supply of Sites with Study Materials/Supplies necessary to effectively conduct Clinical Study

  • Processing of payments to Sites as per executed Clinical Trial Agreements (if CRG is responsible for payments) or support of Sponsor in processing such payments

  • Reporting and management of Clinical Study Protocol Deviations

  • Maintenance of Trial Master File (Site level), performing its quality review and check, resolution of all related Action Item(s)
  • Perform Site Close-out Visits (face-to-face or remote) to (non-exhaustive list): 1) formally document the completion of the Clinical Study; 2) ensure consistent and accurate processes are maintained throughout the entire Close-out process; 3) confirm all Clinical Study documentation is available and can be archived; 4) confirm resolution of data queries; 5) verify that the Principal Investigator understands post-study obligations. Each Site Close-out Visit is carefully planned, conducted, reviewed and reported in written respecting the agreed with Sponsor timelines/requirements

  • Perform final post-Close-out activities (non-exhaustive list): 1) support of Site in return of supplied study equipment (as applicable) and finalization of corresponding supporting documentation as per country-specific requirements; 2) support of Site in processing of the final payment as per executed Clinical Trial Agreement; 3) support of Site in receipt of final completed Case Report Forms; 4) provision to Site and support in Institutional Review Board/Independent Ethics Committee submission of final Clinical Study Report as well as obtaining of all necessary confirmatory documentation for Sponsor

Pharmacovigilance & Safety Support

  • Submit expedited safety reports, Development Safety Update Reports, Periodic Line Listings to Regulatory Authorities, Central Ethics Committee, Institutional Review Boards/Independent Ethics Committees, and other regulatory bodies

  • Ensure all safety related documentation is kept in the Clinical Study Sites

Third Party Vendor Management

  • Selection, contracting and management of Third Party Vendors for a particular Clinical Study (e.g., central laboratory, patient concierge services, local depots for storage and distribution of Investigational Medicinal Products/Devices etc.)

  • Proposing to Sponsor the services of CRG qualified Third Party Vendors and their respective management if approved by Sponsor

Project Management & Administration

  • Maintain Clinical Study Project communication with Sponsor through e-mail, teleconferences etc. Resolve and mitigate all project issues and items requiring attention

  • Generate detailed Project Status Reports including Clinical Study Project Key Performance Indicators as applicable

  • Maintain Project in Sponsor-provided Clinical Trial Management Systems as applicable

  • Maintenance of Trial Master File (Trial level), performing its quality review and check, resolution of all related Action Item(s), its final delivery to Sponsor

Data Management Support

  • Review of Sponsor-provided drafts of Case Report Form, perform User Acceptance Testing of Case Report Form and create feedback with suggestions and recommendations

  • Perform and document Site Training on the use of Case Report Form

Clinical Study Quality

  • Perform Co-Monitoring Visits and Site Audits (face-to-face or remote) to verify that the Clinical Study Site Staff work according to the Sponsor, Clinical Study Protocol, Regulatory, Controlled Documents, and ICH GCP requirements. Each Co-Monitoring Visit and Site Audit are carefully planned, conducted, and reported in written respecting the agreed with Sponsor timelines/requirements

  • Support CRG Project Team in all inquiries related to Clinical Study Quality. Cooperate with Sponsor’s QA Department to ensure overall Clinical Study compliance with applicable quality standards

  • Oversee, approve, and support management of Corrective Actions Preventive Actions as applicable

Subcontracted Services

  • Obtaining applicable country specific Import/Export License(s) for Investigational Medicinal Product(s)/Medical Device(s), laboratory kits, Clinical Study equipment, materials etc. Importation and exportation procedures for the above

  • Sourcing, Packaging and Labelling of Investigational Medicinal Products/Medical Devices, Comparators, Concomitant Medications

  • Transportation, storage and distribution of Investigational Medicinal Products/Medical Devices, Comparators, Concomitant Medications in Clinical Study

  • Return and destruction of unused and used Investigational Medicinal Product(s)/Medical Device(s), laboratory kits, Clinical Study equipment, materials etc

  • Patient concierge services: travel to/from Sites, lodging, meals delivery, reimbursement

  • Central Laboratory services: development of laboratory kits and supporting documentation, processing of laboratory samples, data transfers between laboratory database and Case Report Form, resolution of laboratory related queries