ClinDatrix Quality

ClinDatrix emphasizes quality in our support of our clients. Using leading-edge management practices, we have implemented systems and processes for ensuring accuracy and consistency in all of our activities, and we continually monitor and measure ourselves against best practice standards. Quality reports to Dr. Louise Murphy, President and CEO.

The pillars of our quality program are:

People

ClinDatrix hires and engages pre-clinical, clinical, medical safety, data management, statistical, regulatory and medical writing personnel who are knowledgeable (technically and clinically) and who are experienced. As ClinDatrix employees or consultants, our team members are trained in ClinDatrix systems and processes. They are often cross-trained across disciplines to enhance their overall knowledge and experience of the clinical development process.

Procedures

ClinDatrix has implemented and closely adheres to a full suite of clinical, medical safety, data management, statistical, regulatory, information technology and general SOPs (standard operating procedures). Our SOPs are compliant with Good Clinical Practices, FDA guidelines (including 21CFR Part 11 and HIPAA) and ICH guidelines. All of our SOPs are available, by appointment, for our clients’ review.

Standards

To expedite accurate and consistent results, ClinDatrix uses document templates for forms, meeting minutes and reports – and makes the templates available for our clients’ use as well. ClinDatrix is licensed and certified in the use of standard coding dictionaries (MedDRA and WHO Drug). We also maintain standard job descriptions for our staff members and sustain standard training programs to guide each employee’s advancement.

Systems

The equipment and systems selected by ClinDatrix are implemented in accordance with good scientific and technological practices. All have been appropriately validated through Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The validation documentation is available for sponsor review and inspection by appointment at ClinDatrix headquarters. Further, specific computer servers are dedicated solely to storing data, thus ensuring data security.
Our systems and software include:

  • ClinDatrix uses and relies on a proven suite of clinical and data management software. Clinical data is collected and stored in a secure environment using Oracle Remote Data Capture (RDC) Onsite, Oracle’s electronic data capture (EDC) system using eCRFs, or Oracle Clinical using paper CRFs. ClinDatrix also has Oracle Argus available for the management and reporting of safety information such as adverse events or serious adverse events.
  • ClinDatrix has implemented the SharePoint-Montrium clinical trial management system for secure, global access to clinical trial documents.
  • ClinDatrix supports its regulatory affairs clients with the LORENZ docuBridge software package. The solution organizes electronic submissions to regulatory agencies in electronic common technical document (eCTD) format. With this resource, ClinDatrix provides U.S. and international clients with experienced support across the life cycle of their projects.
  • Further, ClinDatrix has developed two proprietary software programs for use in clinical monitoring. TrakDatrix has both a clinical and a data management module. The clinical module is used for tracking patient enrollment and patient status while the data management module is used for logging and tracking CRFs and queries.
    The second program, TrainDatrix, is a self-paced e-learning system utilized for training clinical site personnel, sponsors and CRAs in the use of Oracle’s Remote Data Capture (RDC) Onsite system.
  • In addition, ClinDatrix has licensed SAS Software for providing statistical analyses of clinical data.