Trial documentation

• Multi-lingual, all sizes inc. USA. Uniquely numbered, if required

• CRFs

• Diaries

• QoLs and PRO’s

Site documentation

• Patient binders – multi-section, different divider styles in one document

• Eligibility criteria cards

• Investigator site files – site kits, multiple binders per site, packaging design if needed

• Mini protocols

• Regulatory binders

• Pharmacy binders

• Manual of operations

Patient recruitment materials

• Welcome letters

• Quick reference guides

• Patient brochures

• Patient study guides

• Emergency cards

• Appointment reminder cards

• Flip charts

Data management

• Scanning of study files – to PDF, indexed, passed back on any format sFTP, disc etc (full data security) – high volume capability

• Duplicating of study files – single copy, indexed/dividers print outs, bound for archive or to sponsor

Clinical operations documentation

• Investigator brochures

• Protocols/ mini protocols

Electronic delivery

• Secure document management solution (DMS) for controlled access to study documents with 2FA enabled

• sFTP access and API integration available

• Downloadable templates for ad hoc distribution

• eBinders via DMS or USBs

• Electronic delivery of HCP mailings