Sponsored by Centaur Clinical
Centaur Clinical, a CRO specialized in Clin. Ops. for your Medical Devices
Centaur Clinical is a Clinical Research Organization that focuses solely in Medical Devices. With the previous or the new revision of the MEDDEV (EU Medical Device Directive), companies need support in helping them with bringing their device to the market, and for that they would CE marking. Centaur Clinical helps Sponsors with their Clinical Operations needs all across the globe.
About Centaur Clinical:
Centaur Clinical was created in 2016 by Dr Waza Hadjebi, focusing mostly on Medical Devices. Very quickly, Centaur Clinical has set up a local team as well as partnering up with different companies all across the world, to be able to meet the Sponsor’s needs.
Centaur Clinical main line of activity is Clinical Operations, but we provide support in the whole process for CE marking such as:
- Medical writing of various documents such as Instructions for Use, Clinical Evaluation Reports and also clinical documentation such as protocol, CRF design, safety reports, ICF, CSR…
- Clinical Strategy: providing the best approach to design the best trial for your company
- Quality: Although Centaur Clinical is small, the Quality system follows approaches of big companies. We are working on getting our ISO 9001-2015 certification and we are all trained in ISO 14155, 13485, CFR 21 part II. ICH-GCP is also respected as well as local regulatory laws.
- Regulatory: Assessing what class your device would be, liaising with notified bodies, submission to local authorities of protocol and amendments, communication with EC/IRB and National Agencies
- Clinical Operations: Monitoring, Project Management, Feasibility, Safety/Materio-vigilance, budget negotiation, contracts
Data management: EDC design, Query notifications, regular reports, Medical Coding
Centaur Clinical has worked across many therapeutic area for Medical Devices, such as cardiovascular stents and valves, Sepsis, Infectious Diseases, Hypertension, Blood Filtering Machines (dialysis, ECMO, cancerous cells filtration..), Imaging Machines (Ultrasound), Oncology (in-situ delivery, vectors, radiotherapy), Dermatology, Rare Disease, Neurology, Orthopaedics and In-Vitro Diagnostics.
What is the best approach for a Sponsor when looking for a CRO:
Generally, a Sponsor will consider the following when choosing a CRO:
- Costeffectiveness: Many companies, particularly young start-ups have still to be careful with their budget and thus they will ask for the CRO to provide the best support for a fair budget. Centaur Clinical mostly work with young to mid-size companies and thus understand their dynamic and what they are seeking. When submitting biddings, we are often among the most approachable companies in terms of pricing.
- Experience in the field: This is an important point as often a CRO can come back to the Sponsor with ideas, potential new sites or countries. Thanks to our extended team, we will always find someone that know of your products, and thus we will be able to provide support in site and country selection. Note also that as scientists, we spend time studying incidence and epidemiology to ensure recruitment of patients will not be an issue with time.
Potential outreach across many geographical regions: Particularly with studies that have low recruitment per country, there will be a need to reach out across the border. We have worked with studies where patients pool were small per country, or when patients have low interest to participate. We have worked in countries in EU, Eastern Europe, LATAM, Africa and Asia.
Thanks to our understanding and a transparent approach to collaboration, Centaur Clinical has set up partnerships with different entities such as CROs (in Eastern Europe, Asia, US, Latin America and South of Africa), Data management and biostatisticians, Reimbursement specialists in Europe, Market Access consultants, Pharmaco and Materio-vigilance specialists, and software providers to facilitate imaging or study management.
We understand that Sponsors worry is that a Vendor of a Vendor may be less strict in terms of quality processes and this is why we have set up a SOP sharing system where we agree to use the same one for each study. Audits remotely or onsite are done to ensure that the Sponsors’ needs are our requirements.
Our Commitment to the Sponsor:
We understand the Sponsor knows well his technology and thus we focus on finding the best approach to have his product in the market. Thus, through a shared risk system, we can ensure that for us your project is not just another project, but a project that if successful will push upward our results as well as yours.
Our Commitment to the World:
Centaur Clinical is dedicated to help local charities. For example, we provide support to a local charity for kids in temporary housing, to help them feel like they have a second home.
Also, Centaur Clinical is determined to reduce the use of paper in the office as well as using renewable energy if future offices.
Our promise to you:
We will bring an expertise that you will find perfect for the needs of your company to bring the product to the market. We know our stuff!