At Keyrus Biopharma, your products, your projects are driving our teams. Placing your interests at the very center of our day-to-day work, we work together to support your successes in clinical development.
OPERATIONAL EXPERTISE AND LEADERSHIP
We cover all your needs from clinical development plan to market, providing standalone or fully integrated services.
Our clinical trial teams are leading your projects from start to completion smoothly and efficiently. Adaptative and lean, our trial management strategy is built according to your needs and goals. At Keyrus Biopharma, we understand and anticipate your challenges.
Using internal expertise and a wide network of consultants, we provide strategic regulatory support and input on your projects to ensure fast and smooth set-up of your clinical studies.
It’s all about data. Your projects, your products and your patients need data. Comprehensive, clean, accurate data. Our biometry team is ensuring data flow, quality and rapid valorisation to speed up your decision making.
In Keyrus Biopharma, we are proud to bridge the gap between science and market. Not only are we transforming raw data into meaningful reports but also we support your communication during and after market access.
Patient wellbeing and safety is the heart stone of our industry. To cover the safety needs, Keyrus Biopharma is providing unmet top level services in Pharmacovigilance and safety, integrating our services in your sytem and teams.
Keyrus Biopharma is certified ISO 9001. But quality assurance is not a supporting service in our company. Quality assurance is part of our process, not only covering GCP and audit but also supporting KPI, risk management to optimise operational delivery.
Tailored and efficient project conduct
Service range from concept sheet development to final report and publication
Fully integrated service range or standalone service
International, all phases expertise on studies
Extensive experience / global footprint
Wide set of therapeutic areas experience
Fully tailored work, using our / your SOPs
Total quality management and continuous improvement
Integration and management of external vendors
KPI driven management
Innovation and IT tools driven methodology
Regular training and courses in project management
Regulatory made simple
Level strategic input on product positioning
Follow-up of international regulations (RegWatch)
Consulting on regulatory submission strategies
Regulatory submissions to National Authorities and Ethics Committees
Conduct of meetings with authorities
Leading data management and valuation
Data management and bio-statistics services from methodology to package submission
Speakers in key meetings: Phuse, SFDS, CDISC, congresses, etc.
Tailored team (mix of junior and senior to minimize cost, not compromising quality)
International hubs and off-shoring (Europe, MENA, North America)
Full integration of the latest technologies and methods for data collection / analysis
Partner with two EDC providers (Xclinical, Medsharing)
In-house design of eCRF and randomization
Experience and expertise in statistical methodology