Who are Simbec-Orion Clinical Development?
Simbec-Orion Clinical Development is the full-service clinical development division of Simbec-Orion.
Founded 19 years ago as a European CRO we have expanded, through consistent delivery of studies in complex areas. Our operations are based in the United Kingdom, France, USA, Germany and Italy. We have operational staff across mainland Europe (Western, Eastern & Central) and throughout North America.
We have in-depth experience of the most challenging therapeutic areas including oncology, rare and orphan diseases, respiratory, dermatology, vaccines and anti-infectives. We are a boutique CRO offering a true full service with an international reach, combined with the level of quality, flexibility and customer service that you would associate with a company whose mission is to:
“Use our skills elegantly to design, execute and deliver our clients’ clinical development needs.”
As a client you will benefit from:
- Working with a company that has the capabilities of a truly full service, international organisation, with a breadth of service, capabilities and expertise not seen outside of the very largest CROs, but with a scale where you matter
- A proven provider offering quality and reliability
- A company that is drawing the best in the industry, biopharma and CRO, to ensure we think and deliver like drug developers
- A lean managerial infrastructure ensuring senior oversight and governance on all the programmes we work on
- A company with experience and expertise in working in some of the most complex areas of clinical research
- Efficient, nimble and responsive customer care
Simbec-Orion Clinical Development has the in-house expertise and access to a global network to support your clinical development strategy. We can offer:
- In-house clinical development experts: medical personnel, regulatory experts and project managers with extensive practical experience in preparing and managing the most challenging studies
- Established relationships with regulatory and ethics authorities in Europe and the USA
- Access to external expert panels of opinion leaders in our key therapeutic areas, from North America and Europe
Simbec-Orion Clinical Development can help guide your strategic decisions early on by;
- Providing therapeutically focused input to your development plan and protocol
- Preparing and submitting requests for Pre-IND and EMA scientific advice / protocol assistance meetings
- Writing and submitting the briefing package for the scientific advice meeting
- Attending the meetings with regulatory authorities
WE HELP YOU MAKE THE RIGHT DECISION, RIGHT FROM THE START – SAVING YOU VALUABLE TIME AND MONEY
Phase Ib - III
Simbec-Orion Clinical Development can ensure speed and success for your early and late phase studies thanks to
- Project Managers, regulatory experts and CRAs with many years' experience complex studies to drive your studies forward
- Established process to help you select the best investigative sites for your study
- Network of investigators in Europe and North America within our key therapeutic areas, with a track-record of successful studies
- Data-driven and optimized feasibility assessment process
- Integrated Oracle eClinical solutions
- eCRF customised for early phase oncology studies to facilitate and speed up the decision-making process for dose escalation
- Seamless delivery to DSMB panels
- In-house IMP management and pharmacy
- In-house central laboratories with established methods for analysing a large panel of biomarkers and capability to rapidly develop methods for novel biomarkers
OUR SYSTEMS AND PROCESSES HAVE BEEN DESIGNED TO ENSURE RAPID AND EFFICIENT START-UP AND CONDUCT OF YOUR ONCOLOGY STUDY
Each clinical study is assigned a seasoned Project Manager who is your main point of contact throughout the study and is responsible for driving the activities of the study team.
Our Project Managers are supported by the most senior and experienced personnel within the company. This occurs informally on an ‘ad hoc’ day-to-day basis and in the more structured setting of monthly Project Review meetings.
“Our systems and processes have been designed to ensure rapid and efficient start-up and conduct of your clinical study”
Our Project Managers ensure that you have:
- Direct access to them and to all other members of your study team as required.
- It is important to ensure that regular communication is maintained throughout the entire duration of the project.
- Established trial management procedures and processes for rapid study start-up and efficient conduct of your study.
- Close cooperation with central labs, data management, IMP management, regulatory affairs etc., to drive your study and keep it on track.
Simbec-Orion Clinical Development’s CRAs are based either regionally or in one of our five offices. This approach enables us to monitor in more than 30 countries of the world in a flexible and cost-effective manner.
As you would expect, our monitors are fully trained in GCP, the therapeutic area and the specifics of your study protocol. However, we also expect our CRAs to pro-actively manage their investigative sites.
Working closely with their study Project Manager, the monitors develop individual management plans for each of their centres – this includes a site-specific recruitment plan based on feasibility work.
Our CRAs also establish productive relationships with the Principal Investigator and other key players; they are responsible for ensuring that the activities of laboratories, pharmacists and other providers are fully integrated.
Simbec-Orion Clinical Development assists many of our clients by providing strategic support on important aspects of their drug development programmes.
- Regulatory strategy
- Orphan drug designation
- Clinical study design
- Obtaining advice from both EMEA and FDA
- Developing clinical advisory boards
- Selection of optimal countries in which to conduct your clinical development programme
Simbec-Orion Clinical Development has conducted studies in more than 30 territories in Western, Central and Eastern Europe, the Americas and Australasia.
To increase our efficiency, we have centralised our managerial personnel in five strategic centres. These operations are based in Greater London-UK, Paris-France, Cologne-Germany, Rome-Italy, Princeton-USA.
Our CRAs are based either regionally or in one of our five offices. This approach enables us to monitor our international studies in a flexible and effective manner
We also have the Simbec-Orion Clinical Pharmacology Campus in Merthyr Tydfil–Wales. The Research Campus incorporates the Simbec-Orion Clinical Pharmacology 58 bed, FiH capable, Phase I unit, project management, IMP management group, data management and the Simbec-Orion Laboratory Services Central Pathology and Bioanalytical laboratories.
Our therapeutic core focus is on Oncology, Rare & Orphan diseases, Respiratory Medicine, Dermatology and Anti-infectives & Vaccines.
Having key foci on Oncology and Rare & Orphan diseases means that we have expertise in developing and managing paediatric studies, often involving some of the most challenging indications.
Click here to view our Therapeutic Expertise
Data Management & Statistics
Simbec-Orion Clinical Development's Data Management & Statistics Departments are intrinsic in the development of elegant solutions to your development needs; whether it is in the design of your protocol or the management of complex Adaptive Trials.
Our Statistics team’s goal is to ensure that your study delivers results with sufficient power to drive valid conclusions, while using as few subjects as possible.
The Data Management team is the ‘boiler-room’ for any study. They will work with you to deliver an efficient Data Management Plan. They ensure that the electronic Case Report Forms (eCRF) and databases are designed and built to exacting standards and are fit for your needs.
Our Group 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 latest FDA & EU regulations at every stage of your product development lifecycle; 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
Regulatory Affairs & Regulatory Strategy
Simbec-Orion Clinical Development’s Regulatory Services team provides tailor-made solution to your Regulatory requirements – from writing a single Protocol / CTD module to providing a comprehensive Regulatory service, across the complete product life cycle. Our services fall into 3 categories: Strategic, Clinical Trial and Marketing Support.
- Strategic regulatory planning
- Due diligence / Gap analysis
- Technical advice on Chemistry Manufacturing Control (CMC)
- Preparation and conduct of face-to face meetings with regulatory authorities
CLINICAL TRIALS APPLICATIONS
- Preparation, compilation and submission of Clinical Trial Applications
- Management of environmental and viral security approvals
- Prepare, arrange and maintain Marketing Authorisations (MA) for Medicinal Products (NCE and generics), Medical Devices, Orphan Products, Biotech & Advanced Therapy Medicinal Products
- Promotional material development and labelling (User testing)
- Regulatory Compliance
- Mock and Pre-Approval Inspections
Medical & Technical Writing
Simbec-Orion Clinical Development's team of Medical and Technical Writers is integrated within the Regulatory Affairs Department offering particularly strong expertise in complex and medically demanding therapeutic areas such as oncology and rare & orphan diseases.
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