Driving Compliance and Business Continuity in Life Sciences with Electronic Signature
If you’re a national or global life sciences company, connecting people in dozens, hundreds and even thousands of offices across countries and continents is nothing new. But the COVID-19 pandemic has made connecting employees and everyone they do business with much more difficult, as most people are working remotely. Adding this new outer ring to traditional communications circles can create compliance and continuity challenges for most businesses, but especially for life sciences organizations.
How do we make sure that new challenges don’t snap that chain at any point from research and development to marketing of a new drug or medical technology?
The answer for life sciences organizations is a robust electronic signature platform. Implementing such a platform to transition commonly used forms and contract workflows to digital formats is one of the first steps in a complete digital transformation of your business.
Let’s explore the accelerated need for digital transformation, talk about new capabilities that a robust electronic signature platform can give life sciences organizations and explain how those new capabilities can benefit patients in our current environment and beyond.
Remote work is now the norm
Virtually every organization had to adjust their work environment in 2020. A recent survey of 681 employers found that 74% said they’ve made changes to their work environment to adhere to new pandemic protocols. For example, 53% said their full-time employees are now working remotely or from home.
For life sciences, that change can be particularly challenging because of the paperwork that drives all phases of work getting done — agreements, audits, compliance, consents, contracts, regulations, submissions and more.
In addition to paperwork, there are regulatory and GxP standards. In the U.S., the FDA regulation 21 CFR Part 11 sets the rules for electronic signatures and electronic records. Read our whitepaper, Simplify 21 CFR Part 11 Compliance Documentation to learn more.
Document challenges in life sciences
In a recent Viewpoint in the Journal of the American Medical Association, three data scientists, including one from Bristol Myers Squibb, discussed the challenges of doing clinical research and conducting clinical trials during the pandemic. They singled out data collection as a specific challenge and going digital as the solution to that challenge.
“To prevent disruption of data collection, trialists should consider approaches such as electronic data capture implemented at home by the patient or caregiver, telemedicine, or telephone interviews,” the researchers said.
Many of the documents required to collect data also require the patient or others to sign the forms. You could buy everyone in your company a printer, scanner, fax machine and Internet connection for their home office. A better solution would be to move to a robust electronic signature platform and connect everyone to that platform electronically from wherever they’re at now and in the future.
By leveraging an electronic signature platform, the documents your employees, vendors, or trial participants need to do their respective jobs can be managed on the platform. Consider the five stops along the value chain and the types of documents and document management capabilities needed at each of those stops:
- Discovery: sponsored research, investigator-initiated research, laboratory results
- Drug or device development: preclinical development, clinical trials, patient consent and enrollment, site initiation, regulatory submissions
- Manufacturing: batch records, standard operating procedures, quality agreements, safety inspections, recall notifications
- Distribution: partnership and distribution programs, vendor and supplier contracts, agency approvals
- Sales and marketing: speaker agreements with healthcare professionals, sponsor agreement with healthcare organizations, order processing, sample tracking, sales agreements
That’s all before a single patient uses your new prescription medication or medical technology. Now think of all the documents and document management capabilities you need after your drug or device hits the market like reimbursement contracts with payers, prior authorization approvals with providers, adverse event reporting with regulators and clinical and financial assistance and education programs with patients.
Documentation before and after approval can get missed, delayed or messed up when everyone is working not just remotely, but also from home where distractions are everywhere. In life sciences, that can delay getting drugs or medical technology to market and in the hands of the patients who need them.
Digital document capabilities
There is a better way, and that is to leverage an electronic signature platform for your most important documents. Transitioning paper forms to electronic signature can help:
- Reduce drug and device development cycle time and costs
- Streamline compliance and reduce regulatory risk
- Improve the patient enrollment experience
- Eliminate sales hurdles
Digital processes can help simplify compliance and business continuity efforts. Plus, the lessons learned now will help continue digital transformation well into the future after the pandemic subsides. You’re learning a new and better way to work now and moving forward.
And timing is everything. Recently, the Centers for Disease Control and Prevention released guidelines for employers on how to reopen their buildings and let employees come back to work in their offices.
Among the recommendations: “Stagger shifts, start times, and break times as feasible to reduce the density of employees in common areas such as screening areas, break rooms, and locker rooms.”
If you’re like most companies, you need a steady flow of paperwork 24/7 to keep moving forward if you want to enjoy the benefits I listed above. For that reason, coming back to work in the post-COVID-19 world may not work with your business model. What will work is an electronic signature platform that lets your employees work from anywhere at any time now and in the future.
Learn more about the DocuSign Agreement Cloud for Life Sciences.