DocuSign for Life Sciences eBook
1 DocuSign for Life Sciences eBook Reducing Cycle Time with the Leading eSignature Solution 2 Reduce Cycle Time Simplify Operations & Approvals Reinvent Processes We live in a mobile, digital era where health information is at our fingertips. With the touch of a button, patients can see test results, track prescriptions, and sign up for clinical research. And yet it still takes over a decade to bring breakthrough treatments to market. Scientific productivity must improve: clinical trials are costly and time-consuming, and regulations mandate increased scrutiny and compliance. The patients who rely on your scientific leadership are expecting more. How are you meeting their needs? While intensive research and study are still a prerequisite for success, there is a better way to develop new products and therapies. Read on for best practices to drive digital adoption in life sciences. Learn how you can use digital tools to: Introduction Improve Trial Enrollment and Informed Consents Key Challenges For Life Science Organizations 37% of trials under-enroll and 11% fail to enroll a single patient (1) Product development cycle takes more than 10 years Average cost per approved molecule is up 50% over the past decade, from $2.8 billion to $4.2 billion(2) Reduce Development Cycle Time and Costs Meet Regulatory & Pricing Demands Growing regulatory scrutiny and requirements are driving stringent sourcing and quality measures, worldwide agency collaboration, and compliance with FDA, EMA, and other regulations Manufacturers need to justify economic and clinical value to patients and payers Patent expiry is a threat: more than $100 billion in lost sales 2009-2012; generics growth at 10% CAGR from 2010-15 (5) Expand Global Footprint China has invested more than $150 billion and opened more than 2,000 hospitals in the past four years (3) Global pharmaceutical market is growing 7.8% YoY, and 22.6% YoY in BRIC countries: nearly 3X (4) Unique patient needs, market access, local operations and pricing demand new business models (1) PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2012/2013; Tufts CSDD, Tufts University School of Medicine (2) 2.8 Bn is average cost from 2002-2006 and 4.2 Bn is average cost from 2007-2011. Source: PwC analysis and EvaluatePharma; Pharma2020 report (3) ZS Roundtable: The Opportunities – and Risks – for Medical Device Companies in Emerging Markets, 2013 (4) Business Monitor International and PwC Pharma2020 report (5) DTTL Global Life Sciences and Health Care Industry Group analysis of Global Generic, Cygnus, 2013 Global life sciences outlook, Monitor Deloitte, 2013. 3 Critical business processes are often still manual, paper-based and disconnected, resulting in cumbersome, time-consuming transactions, reduced productivity, and rising costs. It's a mess out there! The Problem with Paper 4 Inventory Management KOL Agreements Trial Enrollment & Patient Consent Sales & Installation Agreements Clinical Trial SOP Sign Offs Patients Healthcare Provider Partners Employees Suppliers Mobile, on-demand consumers don't deal in paper. Why should you? The Importance of Digital Business In Life Sciences Paper and manual processes are delaying your critical treatments from getting to market. The result? Increasing product development costs and inefficiencies. Digital workflows and signatures save life science organizations an average of $38 per document* which can add up to millions of dollars for your business. Take a look at these hidden transaction costs that show the price of the paper chase in life sciences: *$38 per transaction cost is based on analysis of select DocuSign life science customers from a third party value engineering firm $1 BILLION $500 MILLION TO $1 BILLION $100 MILLION TO $500 MILLION $100 MILLION & BELOW 1.55 M $59M $19M $3.8M $760K 500K 100K 20K X = = = = X X X $38* $38* $38* $38* TRANSACTION AVERAGE COST PER DOCUMENT ANNUAL COST TRANSACTION AVERAGE COST PER DOCUMENT ANNUAL COST TRANSACTION AVERAGE ANNUAL COST COST PER DOCUMENT TRANSACTION AVERAGE COST PER DOCUMENT ANNUAL COST COMPANY SIZE 5 Manage • Reporting • Retention • Audit Trail Execute • Authentication • Signatures • Templates Prepare • Documents • Data • Workflow Advancing Your Digital Investment Wondering how to get to 100% digital? Here's how DocuSign's powerful platform can help. DocuSign allows you to automate complex workflows, validate users’ identities, get signatures, and maintain a digital record of your transactions. The resulting eSignatures are considered more legally enforceable than pen and paper. 6 Connectivity is Key Your life science organization may have digital systems and content management tools. As you extend the impact of your digital investment with digital workflows, authentication, and signatures, look for vendors who allow you to connect to systems you’re already using and to the people who use them. Simplicity, mobility, and efficiency are the name of the game. Here are some of the systems and credentials that DocuSign has integrated with to enable your business to be 100% digital. *Integration with 21 CFR Part 11 capabilities Life science systems Contract management Internal Operations Digital credentials Veeva*, Documentum by EMC, Transperfect* Drawloop, Microsoft Office 365, Salesforce*, Ariba, Revitas, Oracle, Emptoris, Nintex, Apttus Box, SAP, Successfactors, Sharepoint* SAFE-BioPharma, Exostar, QuoVadis 7 Improving 21 Regulatory Compliance Reaching digital nirvana in life sciences means partnering with a vendor who enables you to comply with 21 CFR Part 11, Annex 11, and other global regulations. If you lose sleep thinking about those ever-present audits, you’re not alone. Here are a few ways that DocuSign has invested in regulated, global life science operations. • Two-factor authentication to access and sign • Signature manifestation and meaning including unique ID, printed name, date/time and signing reason • DocuSign audit with Third Party Regulatory Consultancies (updated annually) • Validation maintenance • Test automation options • Subscription-based services to maintain compliance 21 CFR Part 11 Compliance Cloud Assurance Validation Integration & Custom Capabilities Learn more about 21 CFR Part 11 capabilities and options for regulated life science solutions • Robust partner ecosystem • Integrations with Microsoft, Salesforce, Veeva, and others utilizing regulated life science capabilities • REST & SOAP APIs › 8 A New Standard for Security and Trust Trust and data protection are paramount in life sciences and in the digital world. Here are some of DocuSign’s certifications and capabilities that adhere to the xDTM standard which was established to help organizations like yours conduct critical transactions online without exposing them to the risks and consequences of using noncompliant technologies. Security Privacy Availability Universality Read more about DocuSign’s security. Learn more about the xDTM standard and best practices for managing sensitive digital transactions in the cloud. ISO 27001:2013 certified Adherence to stringent data, identity and security requirements developed by Cloud Security Alliance TRUSTe certified and PCI DSS 3.1 compliant Industry leading choice of authentication Carrier-grade architecture Data stored up to nine times across three geographically disparate locations 43 localized languages for signing documents and 13 languages for sending Support for international and regional digital signature standards 9 Use Case Possibilities For Your Life Sciences Organization Internal Workflows Commercial / Go To Market Clinical Testing On sale to Market • SOPs • Device master records • Quality system audits PROCUREMENT MANUFACTURING • SOWs / MSAs • Purchase orders • Supplier contracts • Sample tracking • Sales agreements • Installation checklists SALES HR • Offer letters • HR onbording forms • Expense reporting • IT asset tracking • IT change requests • Incident reporting IT / OPERATIONS • Nondisclosure agreements • Internal compliance • Patent registrations LEGAL • Clinical site initiation • Lab procedure sign off • Certificates of analysis Phase 1 Phase 2 Phase 3 • Clinical trial SOP sign off • Trial recruitment & consent • Change control sign off • Audit reports • Premarket notification • Labeling Pre-Clinical Testing Regulated R&D Processes Life science organizations reduce development time and costs by using DocuSign. From vendor agreements to regulatory submissions, the fully digital world provides a wealth of applications for completing your critical business documents. Where will you begin? 10 LAUNCH WEB-BASED TRIAL REGISTRY Digital Workflow: Clinical Trial Recruitment Create a PowerForm COMPLETE TRIAL REGISTRATION • Guide patient through completing and signing embedded online trial registry form VALIDATE IDENTITY • Provide email authentication and unique ID code to patient • Learn about other authentication options here MAINTAIN STUDY RECORDS • Keep digital copy of patient's e-consent in secure repository for patient & research staff CONFIRM STUDY PARTICIPATION • Notify patient about trial eligibility & dates • Direct patient to review and complete informed consent • • Direct patient to trial registry sign-up through social media, online ads, and website so patient can register for trial online Improve clinical trial enrollment by accessing a broader, mobile patient population with a fully digital trial recruitment process 11 Digital Workflow: Investigator 1572 Form Improve process for filing new drug applications and begin trials sooner by simplifying investigator credentialing and FDA approvals • Upload Investigator 1572 form • Specify recipient(s) and workflow routing, including authentication and compliance controls * • Tag document with form fields and signature tags • to use templates • Enter investigator name and email address • Send for completion and signature • Fill out investigator name and contact information and attach credentials • Indicate information about clinical investigation, lab facility, and responsible IRB • Authenticate and specify reason for signing ** • Notify investigator and other research parties via email that investigator form is complete • Search and access document and transaction record as needed CREATE TEMPLATE FOR INVESTIGATOR FORM USE TEMPLATE COMPLETE FORM MAINTAIN FORM RECORDS Learn how ** Required by FDA 21 CFR Part 11 regulations in the US market * Pre-packaged account configuration, signature-level credentialing , signature meaning, and signature manifestation (printed name, date/time, and signature meaning). Learn more about regulatory compliance features here 12 Jiji John, Senior Director of Strategic Sourcing, McKesson Turnaround time reduced from 4 days to less than one hour Testimonials & Impact • Signatures obtained in less than a day for 82% of envelopes and less than an hour for 43% of envelopes • Achieved goals of business simplification and pipeline acceleration Large Fortune 500 Pharmaceutical Leading Global Biopharmaceutical • Contract completion took up to 6 weeks, now Just 3 days • Slashed turn-around time by 93% • Savings of $57 per document To have something that works and works so quickly and easily and have customers say we provided them with the best signature experience has been a big win. Director IS Platform Large F500 Pharma Company “ “ Since we started using DocuSign in McKesson Specialty Health’s procurement process, our team has become significantly more efficient – now most contracts are DocuSigned almost instantaneously. “ “ 13 Sign Up For a Free Trial › Sales: (877) 720-2040 email@example.com CONTACT Try an Interactive Demo › Copyright 2003-2017. DocuSign, Inc. is the owner of DOCUSIGN(R) and all of its other marks (www.docusign.com/IP). All other marks appearing herein are the property of their respective owners. DocuSign is changing how business gets done by empowering anyone to transact anytime, anywhere, on any device with trust and confidence. DocuSign keeps life moving forward.