MedaSystems for

Cures Act Compliance

A solution for pre-clinical communication & compliance

Sample expanded access policy form

Expanded Access policy

  • Template policies, including FDA-suggested language

  • Enumerate criteria for making decisions

  • Provide contact information

  • Outline request and adjudication process

Expanded access inquiry form

Physician request form

  • Custom fields are based on needs

  • Avoid receiving patient information via non-secure email

  • Optional patient-facing inquiry form

Reporting dashboard for clinical communications

Respond to requests

  • Analyze interest by geography and institution

  • Connect eligible patients with clinical trials

  • Ensure compliance with global information security standards including HIPAA and FDA 21 CFR Part 11

  • Exportable audit trail of all communications

  • Tailored

    Templates enable the rapid development of a policy to fit clinical rollout.

  • Easy

    Easily post and manage a policy and a customizable intake form.

  • Secure

    Receive inquiries through a secure web form.

  • Informative

    Gain insights to assist with commercialization.

  • Compliant

    Stay in compliance with regulatory requirements.

Comply with FDA requirements for communication

FDA requires life science companies in Phase 2 or 3 clinical trials to publish an Expanded Access policy, including providing a way to communicate with the company and an overview of how requests are adjudicated.

MedaSystems Compliance module allows companies to:

  • Develop a policy

  • Post the policy and the process for making requests

  • Securely receive requests in an auditable, compliant format

  • Gain market insights in advance of commercialization

  • Seamlessly transition to the full MedaSystems platform if Expanded Access becomes a part of the company’s strategic direction

Example expanded access policy webpage

Why do you need an Expanded Access policy on your website?

The 21st Century Cures Act requires companies developing investigational therapies to publish their expanded access policy. A recent study estimates that 90% of companies are not yet fully compliant.

All policies, even if Expanded Access is not offered, must include:

  • Contact information and request process

  • Criteria for evaluating requests

  • Expected time to acknowledge receipt

Even if the company is not offering Expanded Access, proactively explaining why the company may not be able to accommodate requests provides transparency and responsiveness to patient inquiries.

Request our white paper to learn more about requirements specific to the United States.