Learn about Pilgrim Software's SmartSolve solution and how the EQMS solution provider is helping life sciences companies close the quality loop.
LNS Research recently attended Pilgrim Fusion 2018, the customer conference for Pilgrim Quality Solutions. Pilgrim Quality Solutions is an enterprise quality management software (EQMS) company that is primarily focused on (but not limited to) the Life Sciences industry
Pilgrim, now an IQVIA Company
The most obvious change since the last Fusion was Pilgrim being acquired by IQVIA, a $10 billion technology, consulting, and managed services firm with deep contract research organization (CRO) and data roots that has been rapidly building a broad life sciences technology arm through a series of acquisitions, including Pilgrim (October 5, 2017). IQVIA is now in the process of assembling end-to-end “concept-to-market” technology offerings using an open “platform of platforms” approach to the market. This open approach uses a best-of-breed set of technology, in addition to their IQVIA’s domain expertise, analytic capabilities, and data from pharmacies and other sources. IQVIA is attempting to leverage this combination to accelerate clinical development, product approval, product commercialization, while also maintaining quality and compliance. The Pilgrim acquisition fits into the ‘quality and compliance’ piece of the puzzle.
What’s New in Strategy: Next-Generation Quality, Customer Intimacy, and Project Kelsey
Rick Lowrey, General Manager of Pilgrim, kicked off Fusion 2018 by reaffirming the company’s commitment to “customer intimacy,” a concept introduced at the last Fusion conference. Lowrey then introduced the concept of next-generation quality. As an IQVIA company, Pilgrim envisions next-generation quality traversing the product lifecycle in an increasingly autonomous fashion. The autonomy is a result of combining Pilgrim SmartSolve EQMS with IQVIA Apollo™ user experience and Ada™ machine learning enabling technology. Lowrey also reiterated Pilgrim’s commitment to the company’s core customer base through ‘Project Kelsey’ (named after Dr. Frances Kelsey). Project Kelsey focuses on two pillars: EU medical device regulations, and the company’s Biopharma Roadmap initiatives. As such, the project aims to broaden Pilgrim’s functional boundaries, expanding its focus to include Design Control, Technical File, and broader Pharmacovigilance and Safety capabilities.
What’s New in the Platform: SQM Module, Compliance Standards
Pilgrim has driven sustained organic growth with several platform enhancements as well as the recently expanded release of supplier quality management (SQM) module; the company also detailed a string of investments in the platform, Cloud, analytics, and automated validation technology. My discussions with the customer base have shown that past investments in the Cloud were well received by customers, scoring especially high on ease of administration and scalability.
In addition to the enhancements mentioned above, Pilgrim has also been focusing on compliance standards such as ISO 13485:2016 and now EU-MDR. The platform is expected to be entirely EU-MDR compliant by 2019, thanks to the continuous release of guidance documents. Of course, now that Pilgrim is a part of IQVIA, this is just a part of the total compliance picture. IQVIA has also had a global compliance platform that consolidates several compliance functionalities and responsibilities.
The IQVIA acquisition of Pilgrim is interesting for all three sides involved:
- Pilgrim: became a part of a much larger organization with significant sales and services resources, and gained access to new IQVIA Technologies, such as machine learning, and IQVIA strategies such as Lexi™, which leverages off-the-shelf enterprise service bus capabilities to connect IQVIA and other technologies
- IQVIA: added an important technology category to its compliance and quality pillar, and now has the domain expertise of a seasoned team of enterprise software executives.
- The Market: the combination of Pilgrim and IQVIA provides some interesting opportunities to automate and improve quality and compliance management in the enterprise level. Additionally, new quality and compliance use cases in life sciences at the strategic level are especially interesting. These strategies are still in their early days and will take 18-24 months to mature.
LNS notes that it is often difficult for technology providers to transition from one type of business to another. We have recently seen issues with hardware providers transitioning to software, and IQVIA is attempting something similar - moving from a services organization to a technology and services organization. While this approach has given rise to new opportunities, there is also a good chance of running into newer roadblocks before we can label it as a ‘successful approach.’ Time will tell how successful this approach is, but success is certainly not a guaranteed outcome, yet IQVIA has scale and domain advantage.