Care Access Quality Policy

Our Quality Policy establishes the strong standards our team must adhere to ensure both our service quality and integrity and our compliance with applicable regulations and laws. They also set forth key elements of our quality system.

Our policies adhere to both ICH GCP Section 2.13 and ISO 9001 standards. The former requires robust quality systems at every stage of a clinical trial to ensure protection of research subjects and data integrity. The latter further reflects our commitment to excellence, customer satisfaction, and continuous improvement.

Through rigorous adherence to ISO 9001 and ICH GCP, we prioritize research- participant and customer centricity, emphasize risk-based thinking, foster a culture of continual improvement, and empower our Care Access teams to actively contribute to our quality objectives.

The Care Access Policies and Procedures includes core documents that Care Access subject-matter experts develop: the Policies, Standard Operating Procedures (SOPs), and instructions used to govern activities. SOPs are organized into categories covering major areas of the corporate and clinical functions. The procedures may also have a list of associated resources, which include attachments (e.g., example or template documents) and guidance materials which can be used to assist with the execution of certain tasks. Care Access Policies and Procedures are reviewed at minimum every two years, or sooner to reflect changes in process or regulations.

Important parts of our Quality Policy include the following:

  1. Organization Charts ‐ ensures everyone on our team has the bigger picture in which their roles fit and understands independent Quality Assurance functions.
  2. Clearly Defined Roles and Responsibilities ‐ ensures everyone on our team knows their part in our quality system and their peers’ parts.
  3. Ethical Considerations ‐ Care Access is dedicated to conducting research adhering to ethical standards to ensure the protection of participants rights welfare and privacy.
  4. Standard Operating Procedures ‐ Comprehensive, robust system of written instructions, to ensure uniformity of performed tasks and functions, that includes change control and management of potential deviations.
  5. Training ‐ Care Access is dedicated to the delivery of role specific training, ongoing education and competency assessment of Care Access staff to enhance skill and knowledge.
  6. Risk Assessments & Simulations ‐ every plan has unique challenges that can only be uncovered and solved through on-the-ground testing; we choose the most critical components of a project to simulate and we learn from that to refine our processes all the way throughout execution.
  7. Quality Control ‐ defined quality control processes performed by operational departments, for all levels of organization, to ensure data are verified, generated, reviewed, and reported per specified protocol and regulatory requirements.
  8. Quality Issues and CAPA Management ‐ ystems to ensure timely, effective, and robust management of quality issues, from all sources, to address detected problems and prevent them from reoccurring.
  9. Independent Quality Assurance Function to ensure systemic review of existing processes and organizational set up, to ensure compliance with regulatory expectations. That includes:
    1. Escalation Management to senior leadership, so problems are visible to management and management can react.
    2. Internal/ External Audits and Regulatory Inspections management
  10. Defined Key Quality Indicators ‐ based on available quality metrics, and feedback, Key Quality Indicators support Senior Management's ongoing review of processes and systems, and drive our quality enhancement efforts and improvement initiatives that demonstrates dedication to continuous improvement of our research processes and systems.
  11. Records Management ‐ to ensure full records lifecycle (regardless the source) from creation, maintenance, use, disposition and archiving is properly followed.

Having strong policies does not get you far enough unless you have robust training for employees. Care Access has a rigorous GCP training program for all staff with responsibilities for clinical-trial conduct.

All Care Access staff participating in work related to clinical trials conduct have completed GCP training and possess a current ICH GCP E6 (R2) training certificate. Care Access ICH E6 (R2) GCP training meets the criteria identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors. Training on GCP is delivered through certified online courses and live interactive sessions. A post-learning assessment is required upon completion of each learning module, with certification issued upon achievement of a passing grade, which is valid for 2 years. A Refresher GCP training is also available for all Care Access staff.