PHARMASEAL

PHARMASEAL provides Engility®, a cloud-based trial management platform built for clinical operations teams in biopharma, medical device, academic and CRO organisations. Engility was one of the first platforms to unify CTMS and eTMF on a single shared data model rather than integrating two separate products, which reduces duplication and automates the workflows between trial management and document control. Engility Connect adds managed, validated integration connectors to third-party systems so sponsors avoid study-by-study integration costs.

Based at the University of Nottingham Innovation Park, PHARMASEAL has been commercially available since 2019 and serves customers across medtech, IVD, pharma, CRO and academic organisations.

At a glance

• Partner type

  Technology vendor (CTMS / eTMF)
• Headquarters

  Nottingham, United Kingdom
• Regions

  United Kingdom, Nordics, DACH, Benelux, France, Spain and Italy, rest of Europe, North America
• Typical clients

  Medtech and device companies, IVD and diagnostics, mid-sized pharma, CROs, academic institutions
• Products

  Engility® CTMS, Engility® eTMF, Engility Connect (managed integrations)
• Trial types

  Phase III–IV, medical device trials, IVD performance studies, observational and registry studies, post-market surveillance
• Validated against

  FDA 21 CFR Part 11, EU Annex 11, GxP validated, GDPR
• Security

  Cyber Essentials, regular penetration testing, GDPR Data Protection Officer
• Hosting and data residency

  Cloud (SaaS); data stored in the EU or UK
• Integration

  REST API and file-based (SFTP, exports); exports to CSV, Excel, PDF and API
• Pricing model

  Subscription per study, with volume discounts from three studies and enterprise licences

Find out more

Visit pharmaseal.co. To be introduced to PHARMASEAL through Ledidi, get in touch. Interested in joining the partner ecosystem? Become a partner.