Who are Simbec-Orion Clinical Pharmacology?
Simbec-Orion Clinical Pharmacology is a full-service facility able to carry out all types of studies, including First-in-Human studies. All on a single, dedicated research campus.
With over 40 years of operations, Simbec-Orion Clinical Pharmacology is one of the most experienced First in Human (FIH) Phase I organisations, having successfully delivered over 1500 Phase I/IIa studies.
Simbec-Orion Clinical Pharmacology commands almost exclusive, efficient access to a population pool of approximately 2-3 million healthy volunteers and patients.
The Simbec-Orion Clinical Pharmacology campus is located in South Wales, near Cardiff, and with easy access to Heathrow. It houses our 58 bed Clinical Pharmacology Unit – one of the largest in the UK; and Simbec-Orion Laboratory Services central pathology and bioanalytical laboratories; and our IMP Management Group.
SIMBEC-ORION CLINICAL PHARMACOLOGY CAPABILITIES
Phase I Clinic
With over 40 years of operation, Simbec-Orion Clinical Pharmacology is one of the most experienced First in Human (FiH) Phase I organisations, having successfully delivered over 1500 Phase I / IIa studies.
Simbec-Orion Clinical Pharmacology has been successfully inspected by US FDA and UK Clinical Pathology Accreditation.
SIMBEC-ORION CLINICAL PHARMACOLOGY FULL SERVICE RESEARCH CAMPUS
As well as expertise in FiH studies including single and multi-dose tolerability Simbec-Orion Clinical Pharmacology has significant expertise in:
- Drug-drug interactions
- Bioavailability/Bioequivalence studies
- PK/PD studies
- Food/Gender effect
- Gamma Scintigraphy
- PoC Phase IIa studies
- Mass Balance/ADME/Microdosing studies
- Phenotyping studies
- QTc studies
With a campus combining a 58 bed Phase I clinical unit, central pathology & bioanalytical laboratories (Simbec-Orion Laboratory Services), ɣ-scintigraphy imaging services, IMP management via pharmacy and our Qualified Person team, integrated data management & statistics, project management & medical writing, Simbec-Orion Clinical Pharmacology provides unprecedented service and delivery.
The Project Management group is located on campus – allowing direct/face to face lines of communication and ensuring a hands on approach with the study team. Our project managers are highly experienced in managing the unique aspects of early phase clinical trials, across a wide range of therapeutic areas and study designs.
To speed studies along smoothly we have:
- Established procedures for management of dose escalation trials
- Established trial management templates and SOPs with a flexible approach to sponsor requirements
- Direct liaison with on campus support departments, including Volunteer Recruitment, IMP Management (Pharmacy), Central Laboratories and Biostatistics
- Established relationships of over 15 years with Wales Research Ethics Committee and their administration office – providing a fast turnaround and minimising risk of delays.
By having the full service support in a single campus environment, driven by experienced project managers, Simbec-Orion Clinical Pharmacology can provide you with significant benefits: speed, responsiveness, reliability of data and cost effectiveness.
Simbec-Orion Clinical Pharmacology offers strong Pharmacokinetics and Pharmacodynamics expertise across many therapeutic areas combined with excellent knowledge of regulatory requirements. We can integrate PK/PD data analyses into all your studies to optimally support your strategic drug development decisions.
Our experts can provide you with:
- Non-compartmental (WinNonLin Phoenix) and compartmental analysis
- Rapid turnaround of PK analysis for dose escalation decisions
- Routine PK analysis for demonstrating bioequivalence
- Pre-clinical PK calculations
- PK/PD input to guide protocol design
- PK/PD modelling and simulation
- Statistical analysis and interpretation of PK and PD outcomes for the Clinical Study Report
- Production of standalone PK/PD report
- Reporting of all analysis in accordance with relevant guidelines
Bioavailability & Bioequivalence Studies
The Simbec-Orion Clinical Pharmacology’s clinical research campus has more than 40 years of experience in performing bioequivalence and bioavailability studies. The campus is strategically placed in Wales, which gives you the benefit of a lower cost and fast start-up environment with access to a large pool of healthy volunteers. Simbec-Orion Clinical Pharmacology is a full-service facility with all departments – including bioanalytical laboratories – located on a single dedicated campus to help you speed your studies along optimally. Your bioequivalence studies at the Simbec-Orion Clinical Pharmacology campus can start as quickly as within four weeks of regulatory submission.
Simbec-Orion Clinical Pharmacology can help you with all aspects of bioavailability and bioequivalence studies for your generic or innovative drugs; selection of an appropriate study design, writing of the study protocol, designing of eCRFs, regulatory and ethics submissions and management, selection and care for subjects, bioassays of drug/metabolites, pharmacokinetic and statistical data evaluation, reporting of study results, and archiving of all study related data.
Central Labs – Bioanalytical and Pathology
SIMBEC-ORION LABORATORY SERVICES – ON CAMPUS CENTRAL PATHOLOGY & BIOANALYTICAL LABORATORIES
Simbec-Orion Laboratory Services is an integrated division of Simbec-Orion Group, based on the Simbec-Orion Clinical Pharmacology’s Campus. Access to our own central labs enables efficient and reliable delivery for your complex studies – close to 40 % of Simbec-Orion Laboratory Services’ experience comes from NCEs.
THE BIOANALYTICAL LABORATORY
Supports all types of clinical studies with:
• Development and validation of complex assays
• Highly selective and sensitive methods
Read more about Simbec-Orion Laboratory Service’s Bioanalytical Lab capabilities here
SIMBEC-ORION LABORATORY SERVICE’S PATHOLOGY LABORATORY
Offers pathology support for clinical trials.
Developed for the biopharmaceutical industry with over 30 years of high quality delivery.
Read more about Simbec-Orion Laboratory Service’s Pathology Lab capabilities here
Our Radioisotopes Laboratory performs radioactivity measurements for human ADME and mass balance studies. Radio-HPLC and LC-MS/MS techniques are then used to investigate metabolite profiles and to assist the identification of putative metabolites
Read more about Simbec-Orion Laboratory Service’s Radioistopes Lab capabilities here
Quality Assurance and QP
ACCREDITED TO THE HIGHEST STANDARDS
Simbec-Orion Laboratory Services has extensive experience in hosting Sponsor Audits and Regulatory Inspections, and has been successfully inspected for US FDA and UK Clinical Pathology Accreditation.
Our highly trained staff includes five Qualified Persons who can support you with:
- Expertise in formulation/CMC advice
- Regulatory advice e.g. IMPD preparation
- Audit of Third Country Sites, GMP Declarations and Certification of IMP upon importation
Healthy Volunteer & Patient Recruitment
HEALTHY VOLUNTEER & PATIENT RECRUITMENT
One of the biggest problems facing Phase I studies is recruiting the right volunteers, on time and in a cost efficient manner
Simbec-Orion Clinical Pharmacology has the teams, processes, and an almost exclusive volunteer pool to help you start – and complete – your study on time.
Some other Phase I units center themselves like clusters in major cities hoping to trawl enough volunteers from large transient populations, often competing with each other for the finite number of potential volunteers.
At Simbec-Orion Clinical Pharmacology we’ve taken a different approach. For the last 40 years we have been based in an area of the country with no competing Phase I units. Within our catchment area there are approximately 3 million potential healthy volunteers and patients.
Simbec-Orion Clinical Pharmacology has a dedicated Volunteer Recruitment Group comprising of clinical and marketing staff focused on ensuring timely and efficient volunteer recruitment and screening
- Our current scheduled First Subject First Dose (FSFD) rate is 99.3% and our current average screening ratio is 2:1
- Focus on healthy volunteer recruitment via social media and digital channels, to increase engagement and drive down recruitment costs
- Significant links with both hospital centres of excellence and General Practitioners to reach patient populations
Click here to find out about Healthy Volunteer & Patient Recruitment.
Simbec-Orion Clinical Pharmacology
Volunteer Recruitment immediate sphere of influence
Biometrics and PK Analysis
At Simbec-Orion Clinical Pharmacology our in-house experts can work with you to ensure the data you want to collect can answer the questions you need answering. From development of the electronic Case Report Form (eCRF) through to PK analysis.
- electronic Case Report Form (eCRF) design, implementation and management
- Data Management Plan
- Annotation of CRFs and Data Specification
- Database design
- Data entry, verification, comparison, query resolution
- MedDRA and WHO Drug dictionaries
- CDISC experience
- Set up activities include protocol review and generation of randomisation scheme
- Statistical Analysis Plan (SAP) agreed with sponsor, prior to database lock
- Statistical analysis & TFLs
- All PK output for the Clinical Study Report (tables, figures and listings) listed in the SAP will be produced by the Statistician using SAS
- The final individual derived PK and t½ calculation graphs will be sent to the Statistician for appropriate listing or figure production
PK analysis is a core skill within Simbec – performed by our in-house scientists
- Non compartmental PK analysis will be performed using validated WinNonLin Phoenix 32 software
- PK analysis will be independently verified by second analyst and QC checked before issue
- Rapid turnaround of PK analysis for dose escalation decisions
- Routine PK analysis for demonstrating bioequivalence
- Final PK analysis for the report QA audited prior to issue to Statisticians for further analysis
Simbec-Orion’s team of Pharmacovigilance experts, drawn from CROs and across the Biopharma industry, work with you to ensure you have the most appropriate pharmacovigilance, product surveillance and drug safety support services for your needs.
We work with you to ensure your products are compliant with the complexities of the latest FDA & EU regulations.
Our team will ensure that you have confidence that you supported for which ever stage of the product development lifecycle you are in; from FiH, through clinical development and pre/post-marketing.
- Safety reporting plan development
- Integration of all local reporting requirements within your studies
- Local submissions (reportable cases, DSUR)
- Support SAE query resolution
- DSMB development and support
Simbec’s specialist clinical trials pharmacy team are solely focused on the efficient management of your drug product. With 5 Qualified Persons named on the Manufacturing Authorisation, Pharmacists & dedicated Clinical Trials Supplies Technicians, our expert team is there to make your study as easy as possible for you, no matter what dosage form you use.
Simbec-Orion Clinical Pharmacology has the capability to work with many different and novel formulations, including preparation of placebo for blinding compliance. We manufacture IMP onsite and release directly to the clinic (including short shelf life products).
We can manage:
- Sterile Products
- Grade A Isolator for aseptic production
- Non-Sterile Products
- Oral solutions, suspensions, topicals, hand filling of capsules, radiopharmaceuticals, solutions for inhalation/nebulisation
- Micro-dosing studies
- Importation of IMP from outside EU
- Primary and secondary packaging,
- Double-blind Randomisation and Code break Envelope Production
- IMPD writing and review
- Annex 13 compliant IMP Label Design
- GMP and GCP compliant
- Controlled Drug (CD) license holder
Simbec-Orion Group’s team of Medical and Technical Writers is integrated within the Regulatory Affairs Department offering particularly strong expertise in complex and medical demanding therapeutic areas such as oncology.
Our Medical Writers work in close association with our Project Managers, Clinical Research Physicians and Statisticians.
Our services include:
- Investigator Brochures
- Presentation File
- Operating Manuals
- Final Reports
- Expert Report
- Rewriting and / or amalgamation of existing Clinical Study Reports