When you absolutely have to recruit patients on time.
We give hope to the patients, and we relentlessly pursue our goal of meeting the clinical study targets by individually crafting and implementing sharp operational strategies.
clinical trial management
Data Management and Biostatistics
Our services are built for regulatory compliance:
- eCRF cloud-based SaaS tools;
- CDASH conformance;
- 21 CFR Part 11 compliance, full validation;
- IxRS, ePRO;
- SAS and R for statistical programming.
Clinical Trial Safety Management
- Safety management database design, validation, and maintenance;
- Coding of adverse events;
- Reporting of Serious Adverse Events (SAE) and SUSARS to the Sponsor and appropriate follow up with the site;
- Expedited reporting of SAE/SUSAR to Regulatory Authorities and Local EC/IRB per local regulations.
The safety of patients is paramount in clinical research, and ensuring compliance with the study protocol or procedures is crucial for the study to meet its stated objectives. Our Medical Monitors are Medical Doctors (MD) that can provide medical oversight of clinical studies across the regions and a wide range of therapeutic areas. We offer medical and strategic consulting and safety review services for clinical trials as follows:
- Medical review and input into study protocols and key clinical study documents;
- Addressing patient eligibility and ongoing medical issues in the protocol;
- Reviewing of all Adverse Events;
- Designing the clinical programs from the selection of indication to protocol design, through key clinical trial documents;
- Recommending, establishing and working with Advisory Boards.
- Internal QA/QC team;
- Verification of study compliance to ICH E6 (GCP), applicable laws, study protocols, policies and Standard Operating Procedures (SOPs);
- Audit of investigational sites and clinical trial vendors.
Accuracy and completeness of clinical trial records are essential for evaluating compliance of the clinical trial with GCP and the integrity of data. We manage the Trial Master File in the course of a clinical trial to ensure that trial documents are accessible by the appropriate individuals and available for regulatory inspections, and allow the Sponsor to effectively manage the trial. Our services include:
- Paper or electronic TMF (e-TMF) management;
- E-TMF platform that has been validated and compliant with 21 CFR Part 11.
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MAKE EXTENDED GEOGRAPHY YOUR ADVANTAGE
• Russia has 1 clinical trial for every 38,000 people.
List of all registered studies is available at ClinicalTrials.gov
CLIENTS SUCCESS STORIES
This Is Your Team. We Make Clinical Trials Happen.