Clinical Ink has announced its acquisition of Digital Artefacts, a health-centric research firm offering a platform geared toward complex cognitive, behavioral, and physiological data capture. Clinical Ink CEO Ed Seguine spoke with Outsourcing-Pharma about the purchase and what it means for the company’s technology offerings, and for its clients.
OSP: How did Clinical Ink come to know about Digital Artefacts — had you partnered with the firm in the past?
ES: Clinical Ink identified 12 strategic themes we believe will impact the industry over the next three years. Three of those themes will require eCOA + sensor expertise:
- Data convergence (EDC, ePRO, ClinRO, sensors)
- Hybrid decentralized trials as a preferred approach
- Therapeutic expertise will require eCOA + sensor expertise
Based on these three themes we exhaustively canvassed the industry landscape to identify the right fit of technology capabilities, expertise in data science and AI, and broad-based experience beyond our industry.
Digital Artefacts (DA) stood out in that landscape evaluation as having clear strategic advantages. DA’s experience in cognitive self-assessment, behavioral monitoring, human factors engineering, and data science brings learnings from the video-game industry, military, self-driving vehicles, and academia to clinical trials. These are capabilities that are only understood at a cursory level within our industry.
Clinical Ink and Digital Artefacts had not previously worked together, but we have both been working in high-complexity therapeutic areas and execution models (Alzheimer’s, lupus, COVID, DCTs) and there are a lot of exciting opportunities to immediately collaborate.
OSP: Could you please offer some insight as to what about Digital Artefacts’ capabilities, core competencies, corporate philosophy, and other aspects make this a suitable match?
ES: Both companies share a heritage of pioneering new technologies and capabilities. Clinical Ink was the first company promoting eSource direct data capture to replace EDC. Digital Artefacts was among the first to patent self-directed cognitive assessments and deploy voice-based data analysis using artificial intelligence.
The excitement about digital endpoints is warranted, but without the ability to anchor these new measurements to the existing eCOA standards, these new advances are “orphaned” — meaning they are insufficient as stand-alone measures. Clinical Ink’s deep experience in eCOA coupled with DA's digital endpoint expertise will help drive regulatory acceptance of digital endpoints — just like we have done with eSource guidance over the years.
Notably, the addition of Digital Artefacts now allows us to drive situational awareness because context matters. Data derived from Digital Artefacts can now increase the richness of our partners’ study data through the convergence of passive and active digital assessments with their wearables and sensors acumen, providing instrumented data collection that complements our existing products and solutions.
The complementary nature of our focus on complex therapeutic areas (CNS, immunology, GI, oncology) makes this a logical fit. Digital Artefacts has deep expertise and success in leveraging data and technology to effectively deliver the context for insight-based decisions that are novel to the healthcare industry but are expected in other industries. Although often overstated, the convergence of data science, AI, and digital endpoints truly has transformational potential in our industry.
The scientific rigor to deliver optimal human health with both active and passive validated assessments throughout a trial aligns to our Clinical Ink mission — enabling automated, in-clinic, and real-world measurements of cognitive and behavioral assessments in complex therapeutic areas. Digital Artefacts, like Clinical Ink, has proven expertise in designing, conducting, and analyzing the most complex studies especially in lupus, CNS, and oncology.
Enabling decentralized trials (DCTs) is not new to either company — we independently engineered our end-to-end platforms to easily deploy the discrete modules — and more importantly combine these modules as specific use cases for customers — regardless of study approach (DCT or traditional) or deployment model (SaaS or Clinical Ink). Clinical Ink has already deployed 75+ BYOD ePRO studies and is well-informed about the complexities inherent in DCT study designs.
Customers trust us and we have an excellent foundation of experience that will continue to grow (starting with the addition of DA customers) and translate to continued financial performance and growth.
OSP: Will DA keep its current brand, or be brought into the Clinical Ink brand fold?
ES: Digital Artefacts will operate as Clinical Ink. The Digital Artefacts products and solutions will be modules within the overarching Clinical Ink platform. We are beginning immediately with the integration of employees, services, data, technology, and Digital Artefacts’ expertise to quickly fold into the overall capabilities and branding of Clinical Ink.
Joan Severson, co-founder and president of Digital Artefacts, will continue to lead Digital Artefacts project efforts. The existing Clinical Ink management team will remain in place.
OSP: Does Clinical Ink have any future acquisitions in the works, or in its sights?
ES: The industry is dynamic and certainly the permanent impact of COVID-19 has been the catalyst of much-needed innovative advancements and adoption. Clinical Ink is well-positioned to continue as the leader in direct data capture, data science, and AI to effectively deliver the context — situational awareness — imperative for all stakeholders to make insight-based decisions.
We will continue to actively evaluate opportunities that will complement our existing solutions and align with our vision of becoming the preeminent clinical trial data company from source to submission.