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Enabling CROs, pharma, healthcare and lifesciences industries with disruptive e-signature and smart document solutions

Srini Dokka, Global Sales Head, MSB Docs, explains the role of digital signatures that is giving an edge in this patient care, sustainability and profitability war to numerous health entities

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Digital transformation has been one of the key methodologies leveraged by health leaders during COVID times. The sector, due to its criticality perforce, maintains a paper chain of approvals, certifications, permissions, tests, prescriptions and patient histories that is unfathomable in scale. The negative carbon impact and lower profitability are seen as a necessary cost of delivering excellence in patient care.

Smart document digital transformation is giving an edge in this patient care, sustainability and profitability war to numerous health entities – including eight out of the leading 10 pharma organisations globally, such as Pfizer, Roche and more. In the case of the UK-based biopharma organisation, its clinical research associates now spend more time on their experiments and less time chasing paper. This has helped them in the process of developing and commercialising new therapies for oncology and rare diseases.

Organisations in the business of health-allied industries across the board have leveraged smart digital document transformation to create hereto unheard-of efficiencies and positive outcomes. Looking at different industry streams, the benefits can be classified as:

Digitisation with speed, life-saving and cost-saving benefits:

  • The healthcare industry is improving its capacity planning and patient registration, patient consent, lab operations, reports creation, routing and storage, discharge summary and billing, insurance claim processing, appointment bookings, prescription management and pharmacy operations, amongst many other functions.
  • The pharma industry has streamlined and speeded up the process of patient contracts, patient consent forms, patient assistance documents, vendor contracts, sales agreements, electronic batch records, Key Opinion Leader (KOL) programmes, clinical trial onboarding and many others.
  • The lifesciences industry has seen gains across clinical trials, lab accreditation, new drug discovery, engagement of lab professionals, audit trail, feedback and training, inspection reports and others.

Protecting sensitive data benefits essential in the heightened legal and social scrutiny environment of today:

  • The digitisation of paper documents has helped in enforcing access authentication to sensitive/critical data that was earlier under the risk of lock and key anonymity.
  • Regular risk assessment is now conducted to ensure continuity of data safety.
  • Data encryption of all documents in transit and at rest ensures further data privacy and protection.

Maintaining compliance with industry regulations:

  • Organisations can adopt and practice the highest standards for security, including ISO 27001, EU-US Privacy Shield and SSAE 16.
  • They are also able to comply with FDA 21 CFR Part 11, EMA, IT Act 2000, and HIPAA.

California, the US-based lifesciences platform powering next-generation trials to develop safe and efficacious treatments, is using smart document digital transformation. They have leveraged it for 21 CFR Part 11 contracts between CRO and pharma companies. The company, thus, accelerated the adoption of digital health in research by providing a low barrier of entry analytics as a service with its big data platform.

Legal enforcement of consents and agreements becomes easier:

  • All documents signed via MSB Docs are legally enforceable under IT Act 2000 (India), ESIGN Act (USA), eIDAS (EU), FIPS 140-2, SOC2 and SOC3.
  • This ensures that the computing power of digitisation is brought to the fore and instances of missing paper trail minimised.

A leading Indian online healthcare service provider deployed smart document digital transformation to provide doctors with the best signing experience possible for onboarding to their platform. They sought a tool that could eliminate the paper-based contract to gain a market edge over other healthcare providers. They turned to MSB Docs to incorporate electronic signatures into their signing contract. With the implementation of MSB, the company streamlined its signing process and reduced the processing cycle time from days to just hours. Electronically signing contracts increased speed and efficiency, which not only resulted in significant savings, but also improved their productivity and compliance. Doctors were able to tie up with insurance providers, manage partnerships and claims faster, more conveniently and securely.

Extraordinary business ROIs and profitability impact enables these businesses to invest more towards excellence and innovation for the benefit of society and patients. Organisations have witnessed:

  • 65 per cent reduction in costs and improvement in efficiency.
  • 38 per cent improvement in customer experience.
  • 39 per cent reduction in errors and delays.
  • 50 per cent reduction in use of paper, and, thus, the carbon footprint.

Additional benefits have accrued to CROs with specialised MSB CRA scan app that gives an edge in developing new molecules and vaccine candidates. The criticality of CRA scan’s ability and contribution have been ably proven in the rapid development of COVID vaccines:

  • Digital transformation using CRA scan app saves a significant amount of on-site time.
  • Data is completely encrypted and secure, and is protected from access by external users.
  • Even documents that require large document scanners are easily managed digitally.
  • The headache and risk of routing documents to the right repository is managed.
  • Easy configuration of metadata with multiple options enables process efficiencies.

There are endless examples of how the health ecosystem is winning the war for better patient care, better sustainability practices and profitability for innovation. The common link across these cases is the optimal use of e-signatures and smart document digital transformation. It may be impossible to do away with paper-based processes, but we can, however, remove nearly all the disadvantages associated with them. We just need to re-imagine the paper and how we interact with it.

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