↑improved audit trail
↓Reduced turnaround times
Aparito is an award-winning health technology company changing the lives of patients. The organisation works with biotech, pharma and Contract Research Organisations (CROs) to provide a more effective and efficient way to carry out clinical research, while improving patient experience of clinical trials and enabling more diverse patient populations to take part in research. It believes that better patient experiences provide better clinical trial study outcomes.
Aparito identified issues around patient and medical consent forms caused by outdated work processes. By embedding DocuSign eSignature within its app and website, the organisation has been able to streamline the agreement process for patients, simplifying the consent and onboarding of clinical trials, while simultaneously improving business efficiencies.
Clinical trials need a digital solution like DocuSign eSignature
Founded in 2015, Aparito is primarily based in North Wales and currently employs 35 staff across software development and office administration. It has developed Atom5™, a Decentralised Clinical Trial (DCT) platform that digitises clinical trials. It allows for clinical studies to be performed anytime, anywhere, enabling patients and their caregivers to participate in research from the comfort of their own homes.
Prior to using DocuSign eSignature Aparito was reliant on paper-based processes for patient intake and general consent forms. The first step of any clinical trial is the ‘Informed Consent Process’, which enables patients and caregivers to understand the risks and benefits of taking part in a clinical trial. This process often involves asking the patient and the doctor to read through together up to 30 pages of printed text before wet signing an agreement. The signed paper document is then scanned, digitised and saved into the system.
“Clinical trials are one of the last industries to be digitised. It is very paper-based, and very clinic-based,” explained Dr Elin Haf Davies, CEO and Founder of Aparito, “and as such, there is a lot of friction that people are just not used to in their other day-to-day activities.”
As a result, Aparito suffered from high administrative costs and slow turnaround times. Additionally, such an outmoded approach to consent forms also posed organisational risks, as paper documents can easily be lost, prove unauditable, and once archived they can be difficult to retrieve.
Creating a seamless digital user experience with DocuSign eSignature
All aspects of clinical trials are highly regulated, requiring a strong digital footprint and audit trail. To better manage this process, as well as ongoing patient consent, Aparito has embedded an eConsent module into the Atom5™ platform.
“We didn't want to confuse either the patients or the clinicians in having to navigate through lots of different infrastructures or interfaces,” said Davies. “Embedding DocuSign eSignature into Atom5™ means from a patient and clinician experience, they don't navigate outside of that interface, making for a seamless user flow.”
The DocuSign API is used to connect DocuSign to the Atom5™ platform and provides Aparito with a regulatory-compliant solution that digitally manages the agreement process and enables the business to meet its compliance requirements. Aparito worked with the DocuSign development team to define and execute the code, finding the process straightforward and well documented.
By integrating consent via DocuSign eSignature into the Atom5™ platform, Aparito has greatly improved the user experience for patients and clinicians. The eConsent form has proven a popular option with patients, clinicians and Aparito itself. 279% more agreement envelopes were sent in 2022 compared to 2021, and the organisation has seen an impressive 86% Success Transaction Rate (STR) from envelopes sent in 2022.
Access via smartphone app or online web platform offers greater flexibility around accessibility and has proven intuitive to use. To date, one in four contracts have been signed via mobile, and this number is only growing, highlighting the effectiveness of the approach. Furthermore, by eliminating paper, patients do not need to carry documentation around with them, or risk losing it, and can readily refer to the digital document at any time.
Aparito has deployed Atom5™ in a wide range of clinical trials, including working alongside the NHS. It’s most recent has been for Therapies for Long Covid (TLC), which is supporting the University of Birmingham. In this instance Aparito brought cutting-edge methodology and technology to advance this area and benefit patients.
“We use DocuSign in the TLC study for eConsent. It's in the initial consent form and it’s there in the Bioware consent form. So, it's entirely for eConsent. And we've now added a nurse validation: nurses said they needed to sign to confirm that the participants had signed, so it's a counter signature, as well.”
Outside of the Atom5™ platform, Aparito uses DocuSign to assist it in running a paperless office, as all contracting and agreements processes are centred through eSignature.
Making DocuSign eSignature a cornerstone of future initiatives
Future growth for Aparito will involve delivering a global presence as a leading Decentralised Clinical Trial (DCT) and remote patient monitoring platform. To achieve this, the organisation is looking to develop deeper ties by incorporating the DocuSign life science module into its processes. The module delivers compliance with electronic signature practices set forth in the U.S. Food and Drug Administration’s 21 CFR Part 11.
Offering authentication, reason for signature, and signature manifestation, DocuSign eSignature will enable Aparito to make executing agreements faster, more cost-efficient, and compliant with regional standards like Annex 11.
“Informed consent will remain the cornerstone of any clinical research and clinical trials that we do,” explains Davies. “So the key part will be to ensure the patient is fully informed of the risks and benefits of the clinical trial. The electronic signature demonstrates that they've understood those risks as a major compliance piece and therefore DocuSign and eSignature will always remain a cornerstone of clinical trials.”