Clinical Science & Drug Development
Decades of Experience available for your project
Our experience has shown us that, often, biotech, small pharma & start-up companies that have yet to transition into post EIM drug development do not always have all the necessary clinical development personnel in place nor a budget to hire a multiple of specialists. Paracelsus Science’s well-rounded experience in drug development can provide „stop gap“ support to help move your company forward into full development or help generate data that will attract interest from buyers and investors…
PSG can bring you more than 30 years of drug development industry experience in all phases of drug development covering diverse therapeutic areas, including oncology, rheumatology and infectious disease.
At Paracelsus Science we have but one aim: making sure that you can run the best possible clinical trial. Whilst we can’t promise your drug study will meet all of its endpoints, what we can promise is that your study will be managed and conducted to the highest standards – putting your needs for the trial foremost.
So, if your company has a great new molecule with great therapeutic potential and you don’t yet have all the experienced staff you need to move forward or if you have insufficient headcount for a project but no budget for or need to increase FTEs. PSG can help.
Clinical Science
We can offer
as needed ClinicalScience services, with particular expertise in
- Clinical Trial Conduct Lead
- Study management team leadership
- Investigator, site staff & CRA training
- Study recruitment support
- Study medical data review and analysis
- Protocol deviation review
- SAE management (SAE review, investigator assistance, SAE narrative writing)
- Post study analysis, “post-mortem” and Clinical Study Report Writing
Drug Development
We can offer
as needed Drug Development services, with particular expertise in
- Study Design & Protocol Writing
- Study Documentation authorship
- Key Opinion Leader Liaison and management
- DSMB and Steering Committee creation and management
- Answering Regulatory Authority Questions
- PSUR updates
- Presentations to peers, senior management and investigators
- Marketing support
Contact PSG Clinical Science & Drug Development
Paracelsus Science GmbH | Dornacherweg 65 | 4153 Reinach | BL | Switzerland
Phone: +41 (0)79 255 9475
Mail: flavioderosa@paracelsusscience.com
About
Dr Flavio De Rosa
PhD | Dip Pharm Med | MSc | FRSM
Dr Flavio De Rosa, founder of Paracelsus Science GmbH, has more than 30 years of drug development industry experience in all phases of drug development covering diverse therapeutic areas, including oncology, rheumatology and infectiology, and with diverse responsibilities – from drug safety analyses, to advising senior management to study design and conduct.
Academically trained (PhD, MSc. Diploma in Pharmaceutical Medicine) with extensive “hands on” experience in medium and large pharma companies and in a specialised CRO, Dr De Rosa has a broad knowledge of the industry and of medicine and experience working with Key Opinion Leaders. With considerable Clinical Scientist experience in the US, Europe and Australasia (Australia, Malaysia, Japan) he has successfully and consistently delivered complex projects and analyses within set timeframes, budgets and to a very high standard.
Dr De Rosa is a fellow of the Royal Society of Medicine
References
Flavio has supported us on a few occasions with comprehensive literature searches. He had a fast grasp of the essential problems and delivered well-structured reports in a timely fashion. It was a pleasure to work with Flavio and we are looking forward to our next project together.
I have found Flavio to be very willing, helpful and reliable. Nothing is too much trouble. His work is meticulous, methodical and thorough, and he always sticks to agreed timelines.
Flavio has worked with me not only in providing innovative concepts for my work with my clients, but also by developing and producing detailed follow up for these concepts. Not only is he really innovative, but he is good on detail and a stickler for meeting his deadlines. I enjoy working with him and look forward to our collaborations