When the world went in to global pandemic shock in early 2020, the race to create an effective vaccine was launched immediately. The severe mortality and the economic impact of the COVID crisis needed the pharma companies to provide an effective solution in an immediate timeframe as hospitals filled up and children lost entire families. Further complicating this dismal scenario was the knowledge that the fastest vaccine to be developed in the world was for mumps in 1960. This vaccine had taken four years to develop from the beginning of the effort to reach the market.
To the relief of the world and beating the greatest odds, on 2nd December, 2020, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK authorised the first COVID-19 vaccine for emergency use. Soon, thereafter, many more vaccine candidates received approval for emergency use, thus, putting the world on the path of fighting the pandemic.
The vaccine-development efforts involved worldwide phase-III trial with hundreds of participants across thousands of clinical trial sites around the world. It had taken just about nine months compared to multi-year timelines earlier. To achieve this vaccine disruption, every aspect of the development process had to be sped up. While arriving at the vaccine candidate was the result of the scientific expertise, the process of clinal trial and approval for one of the first-approved vaccines was aided by MSB Docs.
The conventional methods of drug discovery involved recording experimental data in paper lab notebooks. The data was important as proof of discovery and patent defence. Informed consent forms a crucial part of clinical trials necessary for vaccine approval. The complexity and delays build up when dealing with thousands of volunteers from clinical trial sites across the world and legal requirements of multiple countries needs to be complied with.
The process earlier went through the cumbersome print-sign-scan-mail routine to obtain signatures from witnesses. Once all the signatures were applied, these signed and dated documents were recorded and stored in quickly retrievable format. The time lost in the process due to its sequential nature and the logistics of delivering and retrieving multi-set original documents were unacceptable for the COVID vaccine development time frame. This becomes even more cumbersome when signatures were to be obtained from different witnesses. It is only after their attestation that the documents could be stored as proof of discovery and patent defence.
Vaccine developers needed a scalable solution to cut costs, improve efficiency and accelerate the turnaround time. In an endeavour to improve its process, one of first movers organisation integrated Chemistry Electronic Notebooks (CeN) with MSB digital signatures. With this implementation, they converted the time-consuming paper-based process into an efficient and streamlined digital-signing process which not only resulted in significant savings, but also enabled chemists to spend more time on their experiments and less time chasing paper. Once the whole experiment was complete, chemist directly entered the experiment data into Chemistry Electronic Notebooks (CeN), assigned a witness and proceeded to enter their credentials applying digital signature using MSB. Once the chemist applied digital signature, MSB automatically sent the signature request email to the witness, who then could immediately review the experiment documentation and sign it at the click of a button. Once the witness had applied the signatures, MSB sent the fully executed documents to records management for archival; thus, drastically cutting short the time required for the entire process while ensuring 100 per cent process completion and compliance.
Key benefits of the smart document integration in the vaccine development were:
- The process was non-intrusive and easily fits the way chemists do their daily work.
- It allowed the users to manage documents, sign and access their experiments seamlessly.
- Less time spent on managing the paper and more time in the lab leading to higher productivity and improved output.
- The process of signing and witnessing was faster and traceable leading to greater compliance with internal policies.
- Experiments were signed, dated and time stamped instantly at completion, thus, increasing its long-term patent protection.
- MSB’s detailed audit trail provides further evidence for audits and disputes.
Combined with the expected reduction in records management activities, the estimated savings provide enough ROI on Smart Document Solutions adoption. Some benefits proved more important than ROI. With the Smart Document Solutions, the vaccine developer also acquired legally defensible signature trail for their operations. The automatic date-time stamp embedded within the signatures provides an accurate time of signing of document. This discouraged scientists from waiting a few days before processing their experiments due to the time consumption in getting an experiment’s paper documentation signed and witnessed. The discrepancy in paper processing would, at times, in the past, lead to compliance issues with internal policies and create problems around patent defence many years down the line.
In addition to the time-critical benefits offered by Smart Document Solutions and e-signatures, there are some specific business benefits that MSB is helping pharma organisations with. These include acceleration of internal processes by 90 per cent, reduction in signed and completed document turnaround time by up to 90 per cent, saving money through process efficiency and cost reductions, helping grow businesses by offering convenient and enhanced end-customer experience, reduction in agreement errors from an average of 25 per cent to just 2.5 per cent, and data encryption for privacy and security of business-critical documents.
India, therefore, has not only been the premier manufacturer of COVID vaccines globally with Serum Institute of India. MSB Docs, as an Indian organisation, has also been embedded in the process of vaccine development and approval and we have presented one more aspect of India’s contribution to the world.