EqualClinic I Pharma Solutions I QA Package I Center Validation I Patient Validation I Data Collection
  Center Validation  
  In studies testing new substances together with chemo-radiation therapy the radiation is not the outcome being measured. The radiation therapy has to be homogenous for the test drug effect to be readable. External checks are necessary for this purpose. Experts with enough experience to judge the importance of confounding factors must conduct these checks.  
  EqualEstro’s qualifying procedure makes sure that the centers deliver homogenous,
high quality radiation therapy.

We check the accuracy of the treatment unit’s dose delivery with mailed thermoluminescent dosimeters (TLDs). These are irradiated at the audited site, and the dose is measured by our accredited EqualEstro laboratory in Paris. Dose deviations of more than 5% are not accepted. When IMRT*, Tomotherapy or Cyberknife technique is used, radiochromic film dosimetry is also employed to check accuracy of dose delivery and dose distribution.
The information we collect in our credentialing questionnaire about the center’s equipment and treatment techniques allows us to evaluate their possibilities of delivering the full chain of treatment required by the protocol. The centers are also asked to perform the delineation and to establish a treatment plan for a fake patient, a so-called Dummy Run case. This trains the radiation therapy department on protocol requirements. Our external dose verification software, EqualDose, provides an independent verification of the doses calculated by the treatment planning system. Our international panel of clinician reviewers, who are active experts in the field, then review the plan itself.

  When these steps are approved the center is validated !  
  * Intensity Modulated Radiation Therapy