When we as consumers think about the critical medicines and treatments developed by life sciences organizations, we often don't consider the many data and approval processes inherent in the research and commercialization process. The harsh reality is that despite global investment in breakthrough drugs and devices, the recent slowdown in the clinical and economic efficiency of the development lifecycle imperils the industry. Pricewaterhouse Coopers substantiates this threat of declining scientific productivity, reporting that companies face more stringent regulatory hurdles from the FDA and European Medicines Agency (EMA). Between 2012 and 2018, nearly $150 Billion of revenues will meet death by “patent cliff.”
Compliance and risk management are always top of mind in the shifting landscape of life sciences. And as multinationals continue to expand across borders, reaching global patient populations in BRIC and beyond, they need to meet new and different standards to effectively bring life-sustaining treatments to market.
DocuSign is delighted to have a longstanding partnership with SAFE-BioPharma, a leading life sciences industry association that works to enable pharmaceutical companies to adopt and implement fully digital workflows. Leveraging the SAFE-BioPharma digital identity credential to apply digital signatures and to authenticate a user’s identity, companies are able to comply with digital authentication standards in different regions around the world.
I am honored to have recently attended a SAFE-BioPharma board meeting where I had the distinct privilege of accepting the SAFE-BioPharma DIGI Award for Innovative Product Compliance. The timing was ripe, as the dialogue among SAFE-BioPharma board members addressed the pressing need for life sciences companies to fully embrace digital adoption. I couldn’t agree more; it is high time that we champion efficiency and eradicate our product development cycle’s chief malady: Paper.
“DocuSign is a leader in delivering a secure and compliant platform that enables life sciences organizations to adopt a 100% digital solution,” said Mollie Shields-Uehling, President & CEO of SAFE-BioPharma. "Our member organizations, comprising most of the top 10 global BioPharma companies, realize that moving to secure, compliant end-to-end digital processes is required to modernize business, clinical and regulatory processes and bring medicines to patients faster and at lower cost.”
DocuSign has integrated with the global SAFE-BioPharma digital signature standard to provide fully digital workflows that facilitate compliance with 21 CFR Part 11. We look forward to our dynamic partnership with SAFE-BioPharma and the opportunity to meaningfully help global life sciences organizations develop and commercialize treatments with greater clinical and economic efficiency.
About the Author
Patric Wiesmann joined DocuSign in 2011 and serves as Managing Director for Healthcare and Life Sciences. Patric brings over 20 years of experience in executive leadership, managing global sales and marketing organizations and serving both public and private industries including healthcare, software/technology and consumer products. He previously held Corporate Sales and Sales leadership positions at American Hospital Supply and Baxter International. At DocuSign, he works with senior executives in customer and partner organizations to identify solutions that improve their ability to serve patients and improve compliance across their enterprises and around the world.