First in Human
Delivering early phase trials in healthy volunteers & patients for 50 years
At Simbec-Orion, we support your drug development with exceptional phase I CRO services from our purpose-built, MHRA Accredited Phase I Clinical Trials Unit.
Reaching this significant milestone in your drug’s development, you need a responsive and experienced clinical pharmacology team. With almost 50 years of expertise in the delivery of early-phase clinical trials in healthy volunteers, special populations, and patients.
Experienced teams
Led by scientific knowledge and stewarded by Principal Investigators who have devoted their research careers to clinical pharmacology, our team of highly qualified, dedicated clinical pharmacology staff play a huge part in our success.
Thanks to strong, well-established relationships with the regulatory agencies, local Research Ethics Committees and when required, guidance from our independent Drug Development Advisory Board, our SMEs can support your programme from the outset. They use their deep scientific and regulatory knowledge alongside extensive operational delivery experience, to guide you through initial study design and protocol synopsis to final protocol development. In doing so, they skilfully combine adaptability and responsiveness, with comprehensive capabilities and international reach to design and conduct early phase trials, tailored to your specific regulatory goals.
Innovative & accurate
Phase I
We prioritise participant safety and quality whilst delivering on your study objectives. We conduct a full range of early phase trials in healthy volunteers and patients including:
- First-in-Human (FIH) multi-part adaptive trial designs, including patient cohorts
- 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
On-site support
We have onsite laboratories which provide rapid turnaround and high quality data for sample analysis including safety analysis, biomarkers and drug concentration analysis in a variety of matrices.
We also include full study design, IMP management, ethics and CTA submissions to provide you with a fully integrated and project managed phase I service.
Our broad range of experience in phase I trials covers many therapeutic areas , including CNS, respiratory, dermatology, vaccines and anti-infectives.
Healthy volunteer to patient cohort in a single trial
Our expertise in adaptive trial design has benefitted many of our clients. You can learn more about how this approach took one of our biotech clients from Healthy Volunteer to Patient cohort results in 24 months for a rare respiratory condition here.
Special and patient populations
In addition to our extensive healthy volunteer database of participants with confirmed medical history, we conduct trials in special populations including:
- Post menopausal females
- >65 years
- Overweight / Obese
- Smokers / Non-smokers
Patient populations
We work with our extensive GP network and local consultants for delivery of patient trials in our Phase I unit. Patient indications include
- Asthmatic
- COPD
- Diabetes
- Hypertension
- Rheumatoid Arthritis
- Psoriasis
- Atopic Dermatitis
- Crohn’s Disease
- Irritable Bowel Syndrome.
By conducting patient trials in our MHRA Phase I accredited Unit, you can be assured of the highest safety and quality standards with overnight fully equipped facilities – full resourced by an experienced recruitment and research team.
Each patient trial will include a study specific recruitment strategy including utilisation of our in-house database, GP/primary/secondary care network, direct to patient advertising (through social media or traditional print) and patient advocacy/support groups.
We work with a network of local consultants to support recruitment and trial delivery in patient groups being managed through the secondary care pathway, such as Parkinson’s or Huntington’s Disease. Additionally, this network supports access to therapeutic expertise / specialised techniques that can be incorporated into trial design.
Established partnerships
We have conducted a number of scintigraphy trials on asthmatic and COPD patients using our in-house gamma scintigraphy camera and over 25 years of collaboration with Cardiff Scintigraphics.
The value of Early Regulatory Engagement: How Scientific Advice Can Support your Clinical Development
In our latest webinar, Dr Kirsty Wydenbach, a valued member of our independent Drug Development Advisory Board and Head of Regulatory Strategy at Weatherden, shares her insights on the benefits of early, proactive engagement with regulators through Regulatory Scientific Advice.
A responsive CRO at a critical phase
We appreciate and understand that for small to medium-sized organisations, early phase trials can be critical in securing investment for the future development of their product. Our lean management structure means we are a highly flexible team who will adapt to remove bottlenecks and shorten timelines so you can meet your investors’ expectations.
We will establish governance and project and risk management plans from day 1 to mitigate risk. We understand that complex studies continuously evolve and may require a change in scale or flexibility. When your study needs it, you’ll find our teams are both responsive and equipped with the knowledge and experience required to handle any challenges that may arise.
Our expert clinical researchers and project managers are passionate about supporting clients in driving the drug development forward, running webinars and publishing research papers on the process of clinical development and phase I studies.
Phase I & clinical pharmacology
The established team at our Clinical Pharmacology Unit deliver every function from volunteer and patient recruitment to screening, clinical conduct, and on-site safety and analytical laboratories under one roof. We work with our extensive GP network and local hospitals to recruit specific patient populations for trials being conducted within our unit.
We are also experienced in early clinical pharmacology trials including patients recruited at multi-sites in multi-countries. One such study investigated the safety and pharmacokinetic properties of a study drug in healthy volunteers, followed by an expansion cohort treating patients with a rare disease, idiopathic pulmonary fibrosis IPF
Our clinical pharmacology unit
Take a look at our purpose-built clinical pharmacology unit, which is fully equipped for early-phase clinical trials. Our unit is designed to seamlessly move between trial services – from volunteer and patient recruitment to screening, clinical conduct, and on-site laboratories. We also work with our extensive GP network and local hospitals to recruit specific patient populations for trials being conducted in our unit.
Beyond first in human
With over 460 employees across the UK, Europe and North America, Simbec-Orion is a truly global full-service CRO offering a comprehensive portfolio of services from FiH to phase III and post-market studies. Our clinical trial management services are highly responsive and sufficiently flexible to be built around your needs, allowing you to seamlessly move your product from First in Human to launch with one team.
What our
clients say about us
The Simbec-Orion team have been a brilliant CRO to work with over the last 2 years. You are up there as one of the best units and teams I have collaborated with, you have been open and flexed to accommodate requests when we needed it, and always with a great pragmatic and friendly attitude
Helen Bridger, Biotech Client
