Our Capabilities

CAPABILITIES

Our Capabilites span all phases of clinical and expand beyond those of a traditional CRO. By having both a CRO and SMO function, we are able to leverage resources from both to improve the efficiency, timelines and cost of conducting your clinical trial.

With both functions we are able to deliver the highest quality data, provide greater trial oversight at the country, as well as site level and ensure the safety of patients.

Clinical Trials

We offer a full scope of clinical services for conducting all phases (I-III) of clinical trials in Belarus, inclusive of partnering with CROs on already enrolling trials for recruitment bolstering.

Signal Generating Trials

For sponsors who have early phase products that need to test efficacy and safety, we have our own systems in place where we can be the primary CRO. The high quality validated data we produce can be taken to the FDA as evidence for registrational trials..

Expanded Access Program (EAP)

We can establish and manage your EAP quickly and efficiently with minimal start-up costs and time constraints.

Site Management Organization

Similar to SMOs in the US, we are able to provide clinical trial services to CROs, pharmaceutical and biotech companies, as well as combine operations with our CRO to offer greater streamlined services..

CRO

Our CRO services encompass everything needed to successfully conduct your clinical trial from beginning to end, starting with submission of country-specific documents to close-out visits and clinical study report (CSR) submission?

Our highly trained staff consists of healthcare professionals that have oncology experience, from our CRAs to our medical director. Having this knowledge allows for more efficient trial monitoring and oversight.

In addition, our Centralized Screening Facility ensures every patient, from initial screening through all follow-up visits is assessed by blinded independent central review This will ensure all patients meet study criteria and allow us to deliver accurate data.

Study Start-Up

Site Identification
Feasibility Analysis and Questionnaire
Site Contracting
Investigator Meeting
System Implementaton
Vendor Identification and Contracting
Investigator Meeting

Quality and Safety Managment

Internal/External Audits
Site Monitoring and Audit
Pharmacovigilance
Data Monitoring Committee (DMC)
Ensure ICH/GCP Compliance
Audits
Computerized Systems
Training Programs

Trial Managment

Budget and Milestone Tracking
Project and Vendor Management
Site Monitoring and Management
Query Resolution
CRA Oversight
Medical Monitoring
Data Management
Close-Out Visits and Clinical Study Report (CSR)

Regulatory

Trial Document Preparation
Belarus-Specific Document Submission
Trial Master File (TMF) development
Regulatory Application Submission
Ethics Committee Document Submission
Site, CRA and Monitor Training
Quality Assurance Audits
SOP Development

SMO

As a SMO, our goal is to ensure sites are enrolling the right patient and adhering to your study protocol. We oversee and train individual sites participating in your clinical trials to guarantee protocols are followed, amendments are implemented and patient safety is ensured.

Patients

Ensure Recruitment for Each Site
Establish Patient Referral Network
Patient Outreach Programs
Expedite Site Activation and First Subject In
Patient Care and Counseling

Regulatory Submissions

Ensure all documents are submitted for each site
Translate ICFs and EC Documents as Needed
Oversee EC document submission for Each Site

Trial Managment

Site- and PI-Specific Medical Monitoring
Protocol Execution
Ensure Protocol Compliance
Develop Best Practice Guidelines

Quality and Safety Managment

SAE Reportng
Ensure Data Integrity
SOP Development
Ensure ICH/GCP Compliance