Sponsors Resources
Full support during the clinical trial realization – partnership, professionalism, safety
As the Clinical Trial Support Unit, we offer comprehensive support to sponsors by combining our medical and research staff’s experience with modern infrastructure and in-depth knowledge of legal requirements for clinical trials conducted at the highest level.
Our services:
- The negotiation and signing of contracts
- Budget management and accounting
- Feasibility assessment and trial planning
- Preparation and handling of the trial’s documentation
- Legal and regulatory support
- Quality control and participant security supervision
- Investigational agent logistics and dispensary management (https://www.cancer.gov/publications/dictionaries/cancer-terms/def/investigational-agent)
- Operational and administrative support for the research staff
The partnership process – phases:
- Feasibility
- Documents preparation and acquisition of the necessary permits
- Negotiations and signing of the contract
- Clinical trial realization –recruitment, supervision, Submission of reports
- Trial completion and archiving
Why Partner With Us
- Experience in Commercial Trial Management
- Staff with Expert Knowledge in Pharmaceutical Law and GCP
- Clinical Research Support Centre – a dedicated administrative unit
- Transparent Procedures at Every Stage
- Broad Patient Database and Research Infrastructure: An Early Phase Research Unit and three Clinical Hospitals
Sponsor’s Responsibilities:
- Trial financing
- Provision of the investigational product
- Delivery of the study protocol
- Collaboration on oversight and audits
- Payment of fees related to the Compensation Fund
Contact & First Steps:
- Submission form
- Initial meeting – discussion of needs and scope of cooperation
- Preparation of a feasibility study – assessment of resources and study execution capabilities