What’s your eRegulatory Strategy?

In the last year we’ve met with dozens of research teams to discuss this question. In the process, we’ve discovered that moving to an eRegulatory platform is much more than moving from paper to digital documents.

Formulating a site-wide strategy for eRegulatory means considering 1) the benefits you seek, 2) the transition costs you’re willing to support and 3) the integrations that must exist with your other technologies. We’ll explore those here.

Benefits: The Impact of eRegulatory

Getting rid of paper isn’t the reason to pursue an eRegulatory strategy. Instead, the benefits of eRegulatory are expressed by how your team improves once it moves on from paper. The positive changes fall into these categories:

  1. Team specialization: Today’s best organized sites don’t ask their coordinators to do it all. Instead they specialize with regulatory, contract, and startup project managers. A purpose-built eRegulatory tool allows such specialization to take hold through workflows built for each role.
  2. Team location: Allow your team to work remotely, or take on multicenter research sites—no matter their location. If your solution has eSignatures and tasks, location no longer matters.
  3. Efficiency: Save time across document filing, signature requests, study tracking, and document review tasks. Ask your eRegulatory vendor how time savings are measured, and across what tasks specifically, so you can estimate the savings at your own site.
  4. Monitoring management: Let your team manage monitor visits on your terms. This means controlled access for remote monitoring, and a safe place to aggregate EHR records, lab reports and other source for monitor access.
  5. Reduced risk of audit findings: Moving from half-paper, half-digital processes allows your team to get one version of the truth and cut compliance risk. Your admin team can monitor compliance via reports, impossible to assemble with spreadsheets and binders.

The FDA: eRegulatory and Part-11 Compliance

When dealing with Title 21 CFR Part 11 there are three primary areas a research site, sponsor, or CRO must think about. Florence works with all of our clients to map out each of these core areas and how they apply to their unique circumstances.

Features of Your System – Assurances for audit trail functionality, electronic signatures, security and data integrity, records retention and file formats are a few of the features that must be in place for an electronic system and/or process.

Standard Operating Procedures – Standard Operating Procedures (SOP’s) are required to be established and maintained to govern and describe exactly how things are done at that research site, sponsor, and/or CRO.

System Validation – Controls must be in place that allow research sites, sponsors and CROs to identify when the system doesn’t function as per its intended use. Here you should be utilizing your SOP’s and industry best practices to facilitate the validation process.

Implementation: Beginning eRegulatory

In order to have a successful rollout and capture the benefits above, your team must prepare for change. It’s up to you to kick off the change by communicating your new way of doing business to stakeholders inside and outside your building.

  1. SOP development: eRegulatory-specific SOPs must be developed to ensure a successful audit when the time comes. Your eRegulatory vendor should help your team with guidance and best practices for building these SOPs.
  2. Training: None of the benefits above are attainable without a training program and knowledge base that allows even the most technically timid user to feel comfortable going digital.
  3. Sponsor communications: Avoid surprising your sponsor partners with the digital transition. A planful sponsor communication program avoids surprise and communicates your eRegulatory SOPs in an effective way.
  4. Agency communications: Prep for an audit. The FDA’s guidance on eRegulatory can be boiled down into two points: 1) Make sure your eRegulatory system is 21CFR Part 11 compliant. 2) Ensure your team is ready to use the system to walk an auditor through your documents and audit trail.

Integrations: eRegulatory and your Other Systems

Florence eBinders eRegulatory IntegrationsTo successfully implement eRegulatory, and avoid adding complex and redundant tasks, you must ensure your eRegulatory system becomes the centralized hub of your other technology solutions.

  1. Electronic Health Records System (EHR)Eliminate manual transfer of source documents with instantaneous uploads into a regulatory eBinder. Eliminate paper binders and shadow charts and capture source docs in a compliant and secure way.
  2. Clinical Trial Management System (CTMS)Streamline communication with your CTMS saving you valuable time and reducing the risk of compliance errors. Upload documents stored in your eRegulatory system directly into your CTMS, eliminating the need to download and re-upload into CTMS.
  3. Email: Never miss another email. Forward email study correspondence directly into the appropriate site/study to capture both the body of emails and attachments included to avoid downloading to PDF and uploading every time.
  4. Single Sign-On (SSO): SAML integration that allows your team to log into eRegulatory securely when they log into their main organization system.

Read more about “Must-Have” integrations for your eRegulatory system.

Starting your eRegulatory Journey

Your site should develop a view on eRegulatory strategy whether you’re ready to buy a purpose-built system or not—this analysis can expose hotspots that you may be able to solve first with SOPs, and it can illuminate the total scope of a possible eRegulatory project. To help with analyzing and preparing for a eRegulatory our team has compiled this Roadmap to eRegulatory. The guide features tips and insights compiled from hundreds of successful site, sponsor, and CRO implementations.