Contract Research Organization
Advancing Innovation and Compliance in Life Science through our mid-size CRO
In the fast-paced Life Sciences sector, success relies on keeping pace with evolving new technologies and therapies and embracing innovation. To sell these products, companies must demonstrate significant health benefits comply with health authorities’ regulations. A Contract Research Organization (CRO) offers tailored clinical trial services from regulatory affairs to quality assurance for the pharmaceuticals, biotechnology, medical devices, cosmetics, food, and veterinary industry.
Contract Research Organization Center of Excellence at Amaris Consulting
Our Center of Excellence team can help you in the following areas:
Our offers can be combined to provide the best tailor-made solution.
- Clinical Trials Management
- Monitoring/ RBM
- Clinical Supply Management
- Medical Writing
- Site feasibility and selection
- eTMF/TMF tool, archiving, documentation
- Data Management
- Biostatistics and Programming
- eCRF and Tools
- CDISC standard
- Pre-Clinical and Clinical Submissions
- Authorities’ coordination
- Amendments and Early Access Program
- Clinical Procedure writing
- ISO Environment
- Audits and Compliance
- Global/Local positioning
- eCTD/CTD compilation
- Case evaluation and classification
- PSUR/DSUR writing
- Signal detection
- Call center for cases reception
- AE/SAE/SUSAR reporting
The following is a non-exhaustive list of the sector solutions we provide. If you want to assess the relevance of these solutions to your own industry, please do reach out to us.
Large Pharmaceutical companies
We provide responsive, one-to-one solutions in clinical operations, biometry and regulatory guidance to assist companies in accelerating drug development.
We partner with firms to develop innovative and emerging therapy strategies, offering expert advice specialized in clinical trials management, biometry, regulatory submissions, and safety evaluations.
Medical devices companies
We assist companies in product positioning across various category classes (I, II, III, IVD), providing regulatory expertise to ensure the development of high-performance and safe products.
We ensure product compliance through rigorous clinical research and quality audits, enriched by our strategic focus on regulatory standards.
Cosmetic & Dermato-cosmetics companies
We are specialized in guiding companies to meet the highest regulatory standards thanks to clinical evaluation, in vitro tests and data sciences.
Veterinary drugs industry
We support companies throughout their clinical trials, ensuring regulatory adherence and high performance of their veterinary products.
Why choose Amaris Consulting?
Our Contract Research Organization Center of Excellence team:
is market reactive and adaptable
will provide assistance throughout your product life cycle
is at the crossroad of large consulting companies and middle size CRO
keeps pace with the new technologies such as AI