Busting 8 Common eRegulatory Myths

If you have not invested in an eRegulatory solution, you most likely have a mental list of reasons why. You’re not alone. While a majority of clinical research sites now use a purpose-built platform (61% surveyed in 2020), those who do not often list reasonable barriers to adoption.

After working with over 7,200 research organizations moving to eRegulatory, we boiled down the main reasons we hear into 8 categories. All these fears appear valid at first, and 4 years ago many were, but now data shows a majority of them are no longer a reality.

Busting the Most Common eRegulatory Myths Florence Infographic

8 Common eRegulatory Myths

Myth #1

Principal Investigators will be resistant to eRegulatory.


Principal Investigators account for a significant portion of Florence eBinders usage, with over 230,000 eSignatures processed in eBinders in 2019. They love the ease-of-use and sign anywhere electronically capability. Watch our webinar on ensuring Principal Investigator adoption of eRegulatory.

Pro Tips:

  • The eReg solution must be easy for the Principal Investigator to use. ie: Electronically sign documents any time, anywhere on any device.
  • Don’t be afraid to explain to the PIs how an eReg solution positively impacts the operations teams – they are receptive to that.

Myth #2

My Sponsor or CRO will not accept eRegulatory or eSignatures.


Sponsors and CROs are turning to Florence for remote monitoring, remote start-up, and remote access to clinical trial sites. Sponsors account for nearly 50% of Florence eBinders usage. Download our Ten Tips for Compliant eSignatures Infographic.

Pro Tips:

  • Update SOPs to include new digital workflows and use of eSignatures – this is key for sponsor and CRO acceptance.
  • Demonstrate benefits to sponsors and CROs – remote monitoring means big savings on hotels, flights and per diem.

Myth #3

eRegulatory adds yet another system I now have to manage.


Integrations with existing internal systems Single Sign-on (SSO), and Sponsor connectivity streamline workflows across platforms. Download our Open API Integrations Whitepaper.

Pro Tips:

  • Open APIs at your eReg vendor mean you can integrate with CTMS and other workstream-specific platforms so duplicate work and dead-end workflows are eliminated.
  • Ask your vendor directly if they have an Open API.

Myth #4

The Cloud is not as secure as our paper binders or a solution built by IT.


Florence uses Amazon Web Services to architect eBinders in alignment with HIPAA, CFR 21 Part 11, Annex 11, EMRA, and HITECH compliance regulations. Independent auditors routinely check Florence systems to ensure your security. Read our blog post on 7 Misconceptions about Managing Research in the Cloud.

Pro Tips:

  • Technology enables advanced permission and role-based access heightening safety vs. paper or traditional workflows where secure access, audit trails and data back-up are not always achievable.

Myth #5

Shifting to an eRegulatory Platform will be too expensive.


eRegulatory generates direct ROI through reduced document cycle times (40%), increased study capacity (12%), lower compliance risks, and sponsor connections. Most research sites are reimbursed for eBinders by study sponsors. Download our Guide to eRegulatory ROI.

Pro Tips:

  • Negotiate reimbursements from your Industry Sponsors in your Budgets and CTAs and lean on your vendor to help with this.

Myth #6

The transition to eRegulatory will take too long for my team.


Our expert teams work with you to develop a strategic plan that accelerates onboarding and ensures adoption. Average eBinders implementation takes 8-9 weeks, including training, certification, SOP updates, and document workflow design. Download our Guide to eRegulatory Implementations to see our eReg process.

Pro Tips:

  • Your vendors implementation and change management plan is crucial to seeing the full ROI of your investment and successful adoption. Rushing through this or skipping important steps will result in wasted time and money and potentially, a disgruntled team. Ask your vendor for a detailed plan.

Myth #7

An eRegulatory platform will not be flexible enough for my needs.


Standardized Flexibility in eBinders means you set the structure, the workflows, and the access. You are the decision-maker. eBinders is the intuitive driver. Read our blog about Standardized Flexibility in eRegulatory systems.

Pro Tips:

  • Florence provides the eISF Reference model binder structure to you to modify to your needs. Your vendor should guide your decisions as to both set-up and workflows based on best practices and your organizational needs.

Myth #8

It’s easier to adopt other eClinical tools before eRegulatory.


eRegulatory is essential to kick-off your paperless strategy. Our State of the Industry report revealed that over 61% of Research Organizations plan to adopt eRegulatory in 2020. Download our 2020 State of the Industry Report.

Pro Tips:

  • Florence eBinders best practice is to implement eReg and CTMS simultaneously. eReg’s shorter implementation timeline, coupled with a cohesive change management strategy will ensure both platforms are widely adopted and well thought-out.

Ready to Learn More?

Watch this three-minute video to get an inside look at the day in the life of a regulatory manager on Florence eBinders.