The distinction is we add multidisciplinarity
We combine excellence and experience
Since its founding in 2012, Scandinavian Development Services has grown into a multi-disciplinary team of handpicked specialists with regulatory and scientific knowledge in medicinal product development and statistics. Our ambition is to guide our clients in transforming their research hypotheses into full clinical studies. We adopt a holistic approach in collaboration with our clients to provide the best solutions for each unique project. Our passion is to solve those tricky questions which have no obvious answers.
Meet some of our consultants
Very rewarding to have impact on PRIME
Åsa Karlsson, Senior Advisor in Clinical Development and Regulatory Affairs, about her role in a PRIME* application and award at an early stage:
“I took the lead in the writing process and oversaw the timeline of the submission of the application. It was truly rewarding to add value to a client, while at the same time contributing to the portfolio of EMA´s new initiative that aims to help promising medicines reach patients earlier.”
PRIority MEdicines, PRIME, is a scheme launched by EMA during spring 2016 to enhance support for the development of innovative medicines that target an unmet medical need.
Effective communication is key for the way forward
Anneli Tinnerholm, Clinical Project Management advisor:
My passion lies in transforming scientific research discoveries into full clinical studies. In SDS Clinical Project Management, we work with a wide spectrum of drug-development projects from Phase I (first-in-human) to Phase III clinical trials. Each project is unique with its own challenges to overcome. As a Clinical Project Management Advisor, my role is to guide and support our clients through their clinical development phase from the design of the study, regulatory interactions to coordination of the CROs. Through effective communication and engaged problem solving, it is incredibly stimulating to find the best solution and way forward for each client.
Turning biostatistics from difficult to accessible
Robert Szulkin, PhD Epidemiology, Senior advisor at SDS Biostatistics, about his lectures in biostatistics:
“Most of my students and clients have non-mathematical backgrounds, so they anxiously anticipate the biostatistics course to be daunting and difficult. With this in mind, I try to explain the intricacies of subjects such as logistic regression and survival analysis in an easily accessible way. I truly enjoy teaching and find it rewarding to see that participants by the end of the course, master a variety of statistical methods, which I believe, will be very useful for their future research projects or drug development programs.”
A simple biostatistics tool can be the key to the right decision
Annica Dominicus, PhD, Senior Advisor Statistics, expert on clinical trial design and analysis:
”With increasingly stringent regulatory requirements for efficient study designs and data analysis, each study presents its own challenges and may require advanced statistical theory and simulation. However, even in the most challenging cases, a simple statistical tool, used in the right way, can be the key to taking the right decision. That’s the beauty of this work.”