Clinical Trial
Management Services
As an experienced CRO, we offer full clinical trial management services from subject or patient recruitment and pharmacovigilance, through to laboratory services and data processing.
We are a full-service CRO. Whether it’s early phase, phase II or phase III, we can design and deliver clinical development projects shaped around your unique requirements. We build a relationship with our clients to understand your limitations, goals and timelines for a reliable, comprehensive and attentive service.
Clinical trials
that drive results
We’re a low hierarchy operation and we believe in getting the job done efficiently and with transparency. Your dedicated project manager will drive the project from start to finish, and you’ll have access to the senior management team for face-to-face troubleshooting.
Responsive and adaptable
With strong governance and project escalation communication plans in place from day one, we mitigate risk and work around any obstacles that may arise. We understand that complex studies evolve and may require a change in scale or flexibility. When your study needs it, you’ll find our team to be responsive and have the experience to handle any challenges that may arise.
Case Study
First in Human (Healthy Volunteer) trial moved into a patient study under a single protocol in a matter of months.
A North American biotech sponsor required a Phase 1 study in healthy subjects and primary hyperoxaluria patients for their novel IMP which was an Antisense RNAi Oligonucleotide being developed as a treatment for PH.
Simbec-Orion’s proactive, risk-mitigating plan ensured that the learnings from the HV study were taken forward into the patient arm of the program
Effective site
management
Our clinical trial management services cover the full scope of your project, including site management. You will have a dedicated Project Manager, but our Clinical Research Associates (CRAs) are decentralised, meaning that they are located close to clinical sites. This facilitates close communication, driving patient enrolment and ensuring effective site management.
Our Clinical Trial Management Team
Wendy Hamon
Vice-President, Clinical Development
Nathalie Ernault-Roseau
Senior Director of Project Management
Laura Llewellyn
Director of Project Management
Meeting project milestones
Our clinical trial management services are designed for small to medium drug developers. We understand the importance of meeting milestones to secure investor confidence and additional funding for clinical development. Our agile set-up means we can flex resources to shorten timelines and remove bottlenecks. You can provide data to support your major milestones.
What our
Clients Say About Us
The people working at Simbec Orion are dedicated, very professional and they cover all aspects of clinical research. A team will be set up for your project, who will have a strong focus on your study in a very open minded and friendly atmosphere. The studies I have outsourced to Simbec Orion, have been successfully managed and performed. I will use Simbec Orion in the future and I can strongly recommend them to other pharmaceutical companies.
Tina Lidén Mascher, Head of Clinical Operations
Klaria AB
