Partner brief

DocuSign and USDM Life Sciences
partnership overview
Enabling compliance for regulated operations
The average cost to develop a new drug–$2.6 billion–has doubled over the past decade.1 As pricing
pressures and patent expiries compromise top line revenues, how will your organization sustain
clinical operations? The answer is right under your nose: automating paper-based processes.
Industry experts estimate that 40% of life science R&D costs are linked to paper-based processes.2And while the FDA sets standards for results and protocols along the way, you hold the keys toreducing time and cost throughout the process.
Accelerate product development without compromising quality
Your patients, investigators, and employees are global – and the processes between them should allow them tocomplete agreements quickly, easily and securely while adhering to regulatory standards. DocuSign enables fully
digital workflows and processes with a modern, purpose-built System of Agreement platform.

PrepareAct

Start by importing documents and data from key systems.
DocuSign has pre-built integrations with platforms like
Salesforce, Box GxP, and SharePoint, and our robust
REST and SOAP APIs enable you to embed our regulated
capabilities in other systems and custom apps.

After an agreement is signed, avoid rekeying data byautomatically updating systems and triggering processes.
For instance, you could prompt an update in your Clinical Trial
Management System when a patient completes a clinical trial
enrollment and notify investigators on the study.

Sign

ManageUse DocuSign’s legally binding and secure eSignaturetechnology to authenticate patients, investigators, andemployees around the world. DocuSign integrates withdigital credentials compliant with eIDAS in Europe, andregulated Part 11 capabilities enable two-factor authentication
and an enhanced signature manifestation with printed date,time and unique signer ID.

Access and store agreements in the system of your choice –DocuSign can route completed documents to systems that
reside behind your firewall. You set your own retention policies
and we help you adhere to them. Whether your agreement isa patient consent, a 1572 form, or a quality inspection, similar
steps are involved to complete it. Digitizing a single agreement
can shave days or weeks off your time to market – soimagine the impact when applied to the entirety of yourglobal operations.

1. PhRMA Industry Profile
2. Digital Signatures and Electronic Submissions: How SAFE Can Increase Information Liquidity

DocuSign DocuSign and USDM Life Sciences

Implement and validate with trust and confidence
Global regulatory authorities hold you to a higher bar – and we hold ourselves to it too. Working
together, DocuSign and USDM Life Sciences help you reinvent your business processes whileproviding implementation and validation services that allow you to deploy with ease and expertise.
Consider us an extension of your team.

Working with you every step of the way
A key engagement is grounded in transparency, connectivity, and partnership. Here is what you canexpect with us along the journey.
Consult with DocuSign and USDM Life Sciences
Our teams help you assess the scope and expected ROIfrom investing in digital regulated processes. Under NDA,DocuSign will provide customers with a copy of our Software
Development Lifecycle (SDLC) process, certifications, andinternal policies that enable our product to adhere to global
regulatory standards.

Subscribe to monthly testing reports
The DocuSign Validator for Life Sciences simplifies
compliance documentation by providing reports that contain
results representing selected aspects of DocuSign’s rigorous
internal testing of our regulated functionality, delivered
directly to your team. Reports include screenshots, detailsof specific provisions tested, and the final test results.

Implement digital, regulated processes
Whether you’re a growing biotech or a Fortune 50 medical
device company, USDM Life Sciences has a track recordof engagements with companies like yours. Working as anextension of your team, USDM will modernize your legacy
System of Agreement and ensure your investment delivers
the greatest ROI. This may include integrating DocuSign
with other core systems like your CTMS, CRM, content
management repository, or custom apps.

Perform ongoing validation
Customized to your unique needs and systems, USDM Life
Sciences offers a Validation Accelerator Pack that includes avalidation plan, annual DocuSign audit report, and automatedtesting tools and templates to make your internal validation
simple and turnkey. USDM Life Sciences also offers Cloud
Assurance, a subscription service for ongoing support of new
DocuSign releases, including updated scripts and ongoing
regression testing.

Deliver results that matter
DocuSign and USDM Life Sciences have an established partnership and draw on expertise fromdeployments at top 20 global biopharma and medical device companies as well as high growthlife science organizations.

Let’s get started
Schedule a consultation with our team today. Contact:
DocuSign sales+1 877-720-2040
lifesciences@docuSign.com

USDM Life Sciences+1 888-231-0816
usdm@usdm.com

About DocuSign
DocuSign helps organizations connect and automate how they prepare, sign, act on, and manage agreements.
As part of the DocuSign Agreement Cloud, DocuSign offers eSignature: the world’s #1 way to sign electronicallyon practically any device, from almost anywhere, at any time. Today, more than 500,000 customers andhundreds of millions of users in over 180 countries use DocuSign to accelerate the process of doing businessand to simplify people’s lives.

DocuSign, Inc.
221 Main Street, Suite 1550
San Francisco, CA 94105
docusign.com

For more information
lifesciences@docusign.com+1-877-720-2040