Rapid, streamlined e-signature procedures
Establish an e-signature solution to increase work productivity
Faster confirmation and approval among diverse, concerned parties
Safe, secure management of approved documents
Rapid, streamlined e-signature procedures
Compliance with security standards and global regulations
Support for efficient, contactless work processes for the post-Corona era
Executive Director, LSK Global PS Clinical Data Management HQ
The remarkable advancement and growth of Korea’s medical technology and related services have been accompanied by a steady increase in requested services of Contract Research Organisations (CROs). According to Fortune Business Insights, the worldwide e-signature market is expected to grow from USD 879 million in 2018 to USD 6.1 billion in 2026. Amidst this growth trend, LSK Global PS is considered one of the CROs to watch carefully.
LSK Global PS was founded in March 2000, the early days of new drug development in Korea’s pharmaceutical industry and provides support for all areas from development of new pharmaceuticals, to consulting and clinical studies including pre-approval Phase I through Phase III trials, investigator-initiated research, post-approval Phase IV trials, post-marketing surveillance (PMS) and observational studies. Since its establishment (as of Dec. 2019), LSK Global PS has conducted 1,150 clinical trials and in the process became Korea’s first CRO to carry out a large-scale, international clinical trial of an anti-cancer drug involving 95 testing sites in 12 countries, including the US and others across Europe and Asia.
As LSK Global PS continues to strengthen its leading position in the growing CRO market, the company is also moving quickly on digital innovation of its work processes in response to the contactless era brought about by COVID-19. A key task of major importance for LSK Global PS was the introduction of an e-signature solution, as in every stage of the CRO’s work process, from the commission and execution of a clinical study to the finding of results, rapid confirmation and safe approval among the parties concerned are keenly necessary.
According to Clinical Data Management HQ Executive Director Lee Jeong-Min, “The healthcare field, like other industries, has been experiencing an increasing demand for e-signatures and as a global company, we could no longer put off its implementation. At just the right time, we came across Adobe Acrobat Sign, which turned out to be the optimum, all-around solution for us.”
As a fundamental practice, each step of every clinical trial conducted by LSK Global PS requires documentation that must be confirmed and signed. All data covering every stage of a clinical trial, from the study request and contract with a pharmaceutical manufacturer to planning and execution of the trial, monitoring and analysis and report of the results, are recorded in documents that must be signed by all parties including the project manager, reviewers and certifiers.
As a result, previous work practices in which printed documents had to be delivered in person or sent by mail and then signed, were inefficient for various reasons. It was not uncommon for signatures to be delayed due to unforeseen circumstances such as the concerned party being absent from the office or mail that simply got lost. Moreover, documents had to be checked for the signatures of all parties and then once signed, the documents had to be scanned and stored away for safekeeping.
As Clinical Data Management HQ Executive Director Lee Jeong-Min says, “Because our previous payment methods were so cumbersome, we regularly discussed the introduction of an e-signature solution. In addition to supporting signatures on mobile devices and the convenience of being quick and simple, Adobe Acrobat Sign provides strengthened security and particularly, it’s a solution that supports global security standards and legal regulations and that’s the main reason we adopted it.”
For LSK Global PS, the greatest satisfaction derived from introducing Adobe Acrobat Sign is the convenience of getting approvals. When a document needing a signature is sent to an email address, the signer receives and signs the document in real time. Also, because this can be accomplished on a mobile device, without the need to install an app, simply by touching the screen or using an electric pen to sign the document once it has been reviewed. And, all of this can be conveniently accomplished even outside the office.
Furthermore, Adobe Acrobat Sign has a tracking feature that’s particularly useful as it enables concerned parties to easily check the status of a document for signatures. For example, when a document has not been signed by its recipient, a user can resend the document to a different recipient or simply send a reminder to request a signature from the original recipient. In addition, all details of the signing process are recorded and stored, such as the number of attached files and time of signing. This enables monitoring of the signing process and also creates a paper trail for later inspection and auditing.
As Executive Director Lee Jeong-Min explains, “With the introduction of Adobe Acrobat Sign, we have greatly reduced time spent unnecessarily on signing processes and improved our productivity and efficiency. Acrobat Sign is now recognised as an important solution for LG Global PS in conducting successful clinical trials and in particular, it is essential for us to carry out clinical trials on the global stage.”
Adobe Acrobat Sign brings the guarantee of safety and reliability to the signing process for LSK Global PS. A document for signing that contains an inserted unique link to pertinent information can be sent by email to a recipient and when needed, the document is further secured through user authentication involving encryption, social ID, mobile PIN code, public institution ID etc. Moreover, Adobe Acrobat Sign is totally compatible and linked with Adobe Acrobat DC and Microsoft 365, making it not only convenient to use but also providing the advantage of encryption-based document security.
In particular, Adobe Acrobat Sign fully complies with global security standards and legal regulations such as FDA 21 CFR Part 11 (regulations on electronic records and signatures) required in strictly regulated industries like pharmaceuticals and food and beverage. FDA 21 CFR Part 11 is a provision that legally enforces the linking of electronic records with their signatures. As such, Adobe Acrobat Sign features audit tracking for every project to prevent tampering and manipulation of processes. Additionally, Adobe Acrobat Sign includes ‘Fill & Sign’ functionality that enables the signer to confirm their identity and state a reason for signing a document.
As IT Team Leader Jeong Yeon-Woo says, “In the pharmaceutical industry, a lack of devices and data needed for auditing and tracking of electronic records and signatures is an important issue that can be seen as a non-compliant with regulations and lead to sanctions. Adobe Acrobat Sign is a solution that can prevent such problems and that makes it a very satisfying choice.
Due to the prolonged COVID-19 pandemic sweeping the entire world, many companies and organisations are speeding up their conversion to contactless systems with the introduction of various technologies. Staying a few steps ahead, LSK Global PS also moved up the original date for its implementing of Adobe Acrobat Sign as a preemptive response to overcome the COVID-19 crisis.
“Since we introduced Adobe Acrobat Sign, the level of satisfaction among people working with signatures in our organisation has gone through the roof. Particularly, because of COVID-19 many of us are working from home and the effect has been really positive in terms of efficiency because there’s no need to come to the office for signatures,” said Team Leader Jeong Yeon-Woo.
Due to the rising demand for new drug development since COVID-19, LSK Global PS has been taking advantage of Adobe Acrobat Sign to conduct clinical trials non-stop, even in today’s contactless environment.
The introduction of Adobe Acrobat Sign has made rapid and precise signature processes possible while also bringing high expectation of reduced costs related to postal delivery. Through improved work efficiency and productivity, Adobe Acrobat Sign is also contributing to LSK Global PS’ strengthened competency as a CRO.
Although LSK Global PS currently uses Adobe Acrobat Sign mainly in its Clinical Data Management HQ, the company plans to implement its use in every department and accelerate digital innovation with the goal of digitising all of its documentation.