Accelerating Your Drug To Market

OUR SOLUTION

Our solution is simple, overcome the issues currently facing clinical trials including patient accrual, timelines, budgets, and quality of data.

  • Conduct clinical trials in the untapped Belarus market to reduce the overall time and cost of clinical trials by > 50%, while generating high quality data
  • As a US based company, we use the same high standards used to conduct clinical trials in the US
  • Our novel Centralized Screening Facility allows us to provide the highest quality data by ensuring patients meet all trial eligibility criteria
  • Able to have first patient screened within 120 days of protocol submission to health authorities (Average is 90 days)




COMPETITIVE ADVANTAGE

Our success depends on your success...

Large CROs are often able and willing to absorb the cost implications of a certain amount of mistakes, WE ARE NOT. These mistakes can have catastrophic affects on your trial, your company and ultimately the patients.

The difference between our model and other CROs is that we are intimately involved; woven into the fabric of your trial. We have the time, ability and desire to conduct additional activities to ensure things are going perfectly.

In order to deliver high quality and accurate data to our clients, we have built in various activities for additional oversight.


All patients will be screened at our novel Centralized Screening Facility (CSF) by a Blinded Independent Central Review (BICR) committee to ensure the right patient is selected for the right trial and improve screening and consenting consistency.

A CRA will be present during a patient’s Day 1 visit at their local treatment facility to ensure adherence to trial protocol, systems proficiency, patient safety, and to address any issues that arise. This is vital for today’s complex protocols.

We will be in regular contact with patients and have the ability to document and report any issues the patient is having (including AEs and vendor issues) and ensure local site is aware and able to manage the issues. This can also improve QoL surveys.

The flexibility of this model allows us to accommodate for protocols of varying requirements and timelines.


HOW THE CSF WORKS

Our novel Centralized Screening Facility is located in Minsk in close proximity to trusted vendors and easily accessible for patient travel.

The CSF is staffed with our highly trained oncologists, pathologists, radiologists and other support staff qualified to perform patient assessments.



How do we employ this model to ensure high quality data?

  1. Patient is diagnosed at local hospital
  2. Patient is referred to CSF for BIRC screening assessment and matched to trial.
  3. Patient returns to local clinic where they are treated with trial drug
  4. Our CRA attends day 1 patient visit at local treating facility
  5. Study-specific scans and tests will be sent to CSF for BIRC validation
belarusMap



WHY BELARUS

Infastructure


  • Physicians and support staff have similar training and education to that of their western counterparts
  • Only 11 oncology trials are currently enrolling patients in Belarus (compared to > 5,900 in the US)
  • Healthcare professionals speak English and adhere to western GCP standards
  • Business friendly government eager to provide treatment to patients through clinical trials
  • Infrastructure in place to handle large volumes of patients

Cost and Time


  • Socialized healthcare system allows us to open multiple trial sites simultaneously at a lower per site cost
  • Trials are less expensive due to lower:
    • Institutional and per patient cost
    • Procedure cost (scans, biopsies, PK analysis)
    • Site activation cost
    • Operating expenses
  • Faster accrual because socialized healthcare system allows for rapid patient identification and referral

Patient Population


  • 70,000 newly diagnosed cancer patients annually (Total population=9.5 million)
  • 85%-90% of newly diagnosed cancer patients are un- or under-treated**
  • ~90% of patients want to participate in clinical trials
  • Highly compliant patient population with ~100% retention1
  • High unmet medical need due to lack of treatment options for patients
  • Patients willing to travel more frequently to receive treatment than in the US
Belarus