Functional Service Provider Model (FSP) by Pharmalys
Do you need:
✔ On-time, on-budget delivery?
✔ Seamless study start-up?
✔ Agile and adaptable Project management?
✔ Transparent communication to keep your team aligned?
✔ Proactive risk identification and mitigation throughout your study?
✔ Data integrity and regulatory compliance maintained at every stage?
✔ Harmonised standards across countries, sites and vendors?
Pharmalys has the Project Managers you need!
Partnering with Pharmalys strengthens and extends your team with strategic thinkers and experienced leaders who work in full compliance with your internal SOPs and objectives. You gain the flexibility of outsourcing combined with the reliability of dedicated leadership. Trained in PMI methodologies, ICH-GCP and global quality frameworks, our PMs combine an in-depth understanding of local healthcare systems and regulatory pathways with international best practice.
Download the Project Management brochure and learn more.
Do you need:
✔ Audit and inspection readiness?
✔ Faster site activation?
✔ Reduced monitoring backlogs?
✔ Full compliance with your SOPs?
✔ Lower cost per patient or per visit?
✔ Seamless coordination of all clinical operations activities?
Pharmalys has the Clinical Research professionals you need!
At Pharmalys, we provide sponsors with hands-on expertise and dedicated clinical operations support. Our Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) combine regulatory knowledge, operational excellence and cultural fluency to ensure your trials run smoothly, efficiently and transparently.
Download the Clinical Operations brochure and learn more.
eTMF Solutions by Pharmalys
Do you want to:
✔ Be inspection-ready at all times?
✔ Eliminate missing or delayed documents?
✔ Reduce operational risk?
✔ Accelerate study timelines?
✔ Benefit from cost-effective, fully paperless operations?
✔ Enable seamless remote collaboration across global teams?
Pharmalys offers smarter document management for clinical trials through a cloud-based electronic Trial Master File (eTMF) platform. With over 15 years of experience supporting sponsors, CROs and research teams worldwide, we deliver reliable, compliant and efficient eTMF solutions.
Download the eTMF Solutions brochure and learn more.
We also:
✔ Develop tailored roadmaps for eTMF adoption or optimisation
✔ Define requirements, compare vendors, manage RFPs and guide product evaluations
✔ Coordinate stakeholders to ensure smooth system roll-out
✔ Support system validation (IQ/OQ/PQ), user acceptance testing and regulatory compliance
✔ Develop customised SOPs and training materials, and provide hands-on support to ensure successful adoption
Pharmalys offers specialist TMF remediation and consulting services to help sponsors and CROs maintain inspection readiness and optimise eTMF operations.
Download the eTMF Solutions brochure and learn more.
Contact Us Today to learn about how we can support your success!
