Clinical Pharmacology
Pharmacology trials in healthy volunteers & patients
Our team of highly qualified, dedicated clinical pharmacology staff is based in a purpose-built facility in South Wales, UK. All of our clinical pharmacology services focus on the development of safe and effective use of medicine, investigating the interaction of drugs with the human body.
Every trial, whether in healthy volunteers or patients, is overseen by Principal Investigators who have devoted their research careers to clinical pharmacology. Their expertise is your assurance that your study is in safe hands and will be delivered on schedule.
Quality built-in
from the start
Simbec-Orion’s MHRA-accredited Clinical Pharmacology Unit has delivered over 2,000 clinical pharmacology trials, with all drug types, over nearly 50 years.
Our pharmacology and medical teams combine their scientific knowledge and extensive experience to design and execute First-in-Human trials, both in healthy volunteers and patients. We maintain a strong focus on participant safety, and risk management, whilst adding maximum value to your protocol, through adaptive trial design.
In addition to strong, well-established relationships with local Research Ethics Committees, our independent Drug Development Advisory Board is on hand for guidance when required. Our extensive experience with the MHRA, EMA, and FDA will add further valuable insight to your clinical development plans.
Pharmacology trials in healthy volunteers & patients
We conduct a full range of pharmacology trials in healthy volunteers and patients including:
- Food effect (FE)
- Formulation effect
- Drug-drug interaction (DDI)
- Pharmacokinetic studies (PK)
- Biosimilar studies
- Gamma scintigraphy
- Patient Phase Ib and 2a trials
- Participation in multi-site, Phase 2/3 patient trials
Special & patient populations
Alongside our healthy volunteer database, we leverage our extensive local network of GPs and consultants to deliver studies in many special and patient populations. These include
- Post menopausal females
- >65 years
- Overweight / Obese
- Smokers / Non-smokers
- Asthmatic
- COPD
- Diabetes
- Hypertension
- Rheumatoid Arthritis
- Psoriasis
- Atopic Dermatitis
- Crohn’s Disease
- Irritable Bowel Syndrome.
FiH trial moved from healthy volunteers to patients under a single protocol
How a FiH trial in healthy volunteers successfully moved into a clinical development trial including patients with Primary Hyperoxaluria (PH) under one single protocol in a matter of months.
Leverage AI support for your transition into clinical trials
AI-enabled causal modeling can enhance your nonclinical data when presenting to potential investors. The biotx.ai model is closer to human systems than traditional animal models and therefore offers accurate predictions for efficacy in phase II.
Investor confidence can be further supported by using the AI model to identify a comprehensive suite of biomarker endpoints, ensuring only the most meaningful data is collected during your clinical trial.
Integrated clinical pharmacology support
Our facility is uniquely 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 all the necessary support services co-located within one building ensures smooth communication and operational excellence that delivers results.
Adaptive trial design
Combination and adaptive protocols add value to your clinical trial and can shave weeks from your regulatory submission journey.
We have worked with clients to deliver SAD, MAD, and Food Effect studies, including cohorts of patients when possible, to maximise the potential for efficient, cost-effective, data generation.
As an extension of this experience, our pharmacology clinicians have designed and conducted studies in special populations, moving from healthy volunteer cohorts in our Phase I Clinical Pharmacology Unit, to patient cohorts conducted in sites across Europe, under a single protocol.
Meeting your milestones
Your need to meet your milestones to maintain investor confidence, and secure additional funding for your clinical development, is always top of mind for us.
Experienced leaders in the pharmaceutical industry, we ensure that our project timelines are competitive and resources are flexible.
This 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.
Your clinical 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
