Clinical Pharmacology
Operating from a purpose-built facility in South Wales, UK, our team of highly-qualified, dedicated clinical pharmacology staff play a huge part in our success. Our clinical pharmacology services focus on the development of safe and effective use of medicine, investigating the interaction of drugs with the human body.
Led by scientific knowledge and stewarded by Principal Investigators who have devoted their research careers to clinical pharmacology, you can be sure your study is in safe hands and will be delivered on time.
Ensuring Quality and
Reducing Risk
Simbec-Orion is part of the MHRA Phase I Accreditation Scheme, and has carried out over 2000 clinical pharmacology trials, with all drug types, over more than 45 years. Our extensive experience with the MHRA, EMA and FDA will add valuable insight to your clinical development plans.
We have significant experience in First-in-Human trials with a strong focus on participant safety, risk management and adding maximum value to your protocol through adaptive trial design.
Our pharmacology and medical teams will use their knowledge and expertise to advise on enhancements to your protocol development and study design approach. Our specialist advice will ensure quality is built in from the outset to enable efficient delivery of your early phase results.
Want to learn more? View our case study on working with Immupharma for a pharmacokinetic phase 3 trial of Lupuzor™.
Full-Service Clinical Pharmacology Unit
Our facility is designed to provide a seamless flow of clinical pharmacology services across the unit, from volunteer and patient recruitment to screening, clinical conduct, and on-site laboratories. Having everything in one place ensures an operational excellence that delivers results.
Providing value
Combination and adaptive protocols add value to your clinical development. We have worked with clients through SAD, MAD, Food Effect studies and cohorts of patients.
Our pharmacology clinicians have designed and conducted studies in special populations and moved from healthy volunteer cohorts in our Phase I Clinical Pharmacology Unit, to patient cohorts conducted in sites across Europe. All under one protocol.
Meeting milestones
You need to meet your milestones to maintain investor confidence, and secure additional funding for your clinical development. We keep that top of our mind too.
Experienced leaders in the pharmaceutical industry, we ensure that our project timelines are competitive and resources are flexible. Our flexible approach allows project managers to troubleshoot face-to-face with the entire clinical study team. In doing so, we shorten timelines and remove bottlenecks, so your clinical pharmacology project can be a success.
Data
delivered
Listen to Ceri Edwards, Managing Director of Clinical Pharmacology talking about our extensive experience conducting combination and adaptive trial designs that can save your budget and shave precious weeks from your registration programme.
Customised
clinical pharmacology services
The skills and depth of expertise amongst our team allows us to deliver customised clinical pharmacology solutions. Each of our clients can expect a personalised, bespoke service most suited to the needs of their development program.
We would be delighted to discuss your needs with you.
Navigating the Regulatory
Journey From Nonclinical To Early Phase Clinical Trials
Watch our latest webinar, available on demand. We take a regulatory perspective, analysing the transition from nonclinical to early clinical stages, and identifying the critical areas where your programme can gain an advantage with proactive planning.
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
