Graham Clark appointed Director & CRO of AssureTrace as SoftGroup expands managed compliance internationally
Appointment brings 23 years of healthcare serialization and track & trace experience to AssureTrace as the managed compliance model expands into North America.
SoftGroup is strengthening the international development of AssureTrace, its managed serialization compliance brand, with the appointment of Graham Clark as Director & CRO | AssureTrace.
Graham brings 23 years of experience in healthcare serialization and track & trace, spanning the introduction of the EU Falsified Medicines Directive, the US Drug Supply Chain Security Act (DSCSA) and the expansion of national traceability programmes around the world.
As Director & CRO, Graham leads AssureTrace’s commercial strategy, market development and revenue growth worldwide. His appointment marks the next stage of the brand’s expansion, including the launch and development of its managed compliance offering in North America.
From serialization software to managed compliance
The first generation of serialization was largely sold as a technology project: implement the software, connect the network and operate it internally.
The implementation projects may be complete, but the daily work continues like exceptions, alerts, verification requests, trading-partner onboarding, validation and regulatory change. The challenge is not only cost: serialization depends on specialist knowledge that is difficult to recruit, retain and continuously update as regulations, networks and partner requirements change.
AssureTrace addresses that operational layer by combining managed services with the SaTT serialization platform developed by SoftGroup.
The model is simple: AssureTrace runs the operation; the customer oversees it.
Pharmaceutical companies retain governance and ownership of the compliance outcome while gaining access to the skilled resources and day-to-day execution required to keep serialization running reliably.
This reduces key-person dependency, strengthens continuity and lowers the operational risk of maintaining critical compliance capability entirely in-house. The model is also designed to preserve existing trading-partner connectivity when companies change providers, helping make migration a controlled cutover rather than a network rebuild.
Built on SoftGroup technology and experience
AssureTrace operates on SoftGroup’s SATT platform, which supports 145 pharmaceutical customers across 43 markets with 98% customer retention.
Over the last two years, SoftGroup has supported 36 documented competitive displacements into live production environments.
The managed compliance proposition builds on this foundation by combining technology, regulatory connectivity, skilled resources and operational responsibility in a single service model.
By pooling specialist serialization expertise and operational capacity across the industry, AssureTrace can provide access to that capability through a more cost-efficient model while the primary value remains access to expertise, greater resilience and lower operational risk.
“After 23 years in this industry, I have watched too many good companies carry compliance as a permanent in-house burden. Regulators expect you to own the outcome. They do not require you to staff the keyboard. That is the shift we have proven in Europe, and it is what we are now bringing to North America.”
Graham Clark, Director & CRO | AssureTrace
Leading the next stage of AssureTrace growth
Graham leads the commercial direction of AssureTrace as the business expands its managed compliance model across international markets.
The immediate focus includes AssureTrace DSCSA, EU FMD and VRS editions, alongside the continued development of a service model that moves serialization from software ownership toward continuously operated compliance.
Graham is with the SoftGroup and AssureTrace teams at CPHI Milan, 6–8 October 2026.
Visitors can meet the team at Stand 9D98 to discuss provider migration, managed serialization compliance and future operating models for pharmaceutical traceability.
Learn more at https://bit.ly/4yBaudn
