_edited.jpg)
ABOUT US
Seléos Solutions is a service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known Pharmaceutical companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Seléos Solutions has been an independent CRO since 2017 with a strong foundation in site management and regulatory submission. Building on this foundation, Seléos Solutions has successfully developed and established itself as a service CRO. Operating primarily in Belgium – Netherlands, with headquarters located in Brussels (Meise).
Seléos Solutions is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Seléos Solutions continues to experience exceptional growth and great success.
Quality is our backbone, client-focus is our heritage, flexibility is our strength … at Seléos Solutions we combine “Quality, Time, Service to the best effort”.
Our Mission and Story
Our mission is to provide outstanding quality, on-time delivery, and exceptional customer service to our clinical research partners.
In a time driven business we also need to understand
that quality is one of the major Pilars we can't move backwards
to guarantee the stability of the project.
Kenny Diricks, Founding CEO & Sr. Clinical Research Consultant
Research is to see what everybody else has seen, and think what nobody else has thought.
Albert Szent-Gyorgyi
SERVICES
Site Management,
Site Monitoring
and Remote Monitoring
Our team ensure a proper planning, conduct, patient safety and data quality while maintaining a good communication with sites and sponsors. We will work closely with your team on protocol training, building strong relationships and ensuring site compliance.
High standard of quality, ICH-GCP guidelines and local regulations are without doubt the focus areas of our team. We’re experienced in risk based or full monitoring at site or remote.
Regulatory Submissions
We accommodate a professional, mate to measure approach to your regulatory services, submissions and clinical trial document review.
We are experienced in managing, reviewing and compiling your regulatory dossiers for the Benelux countries.
Feasibility and Site/Investigator Selection
We can assist with your Project Managers to select the best investigators or sites, as of the experienced and positive contacts with a build network of KOLs in several fields.
We make sure that a country/site can be selected as soon as possible to ensure a proper start of your study and make that the investigational site meet the requirements for your clinical trial.
This includes high quality, available potential patients, necessary facilities and expertise and motivated investigators with a dedicated team.
Seléos solutions will provide useful information that would be beneficial for your development phase of the feasibility questionnaire.
Project Management
Seléos Solutions Project Management owns and is intimately engaged in every aspect of your clinical trial. You can rely on your Project Management team to expertly guide our joint project team in capturing all relevant data to support your study goals—with clinical and medical integrity.
Our Project Management will provides ongoing training, support, and review of the clinical data from an operational perspective in consultation with your Medical & Scientific Affairs.
Involvement from our Project Manager begins with the proposal and continues through evaluation and selection of qualified sites, right up to the “last p value.” We believe this dedication and insight can only come from our depth of therapeutic expertise and is core to ensuring rigorous management and mitigation of clinical trial risks.
Project Management include:
-
Preparation of study materials such as the protocol, case report forms, and informed consent documents
-
Establishing necessary documentation for IRB and/or Ethics Committee approval
-
Preparation and support during initial meetings with the FDA, EMEA and other regulatory bodies
-
Pre-investigational visits to train site staff on the protocol, study materials, applicable regulations, and Good Clinical Practice
-
Frequent reports and communications to keep you apprised of data accrual and quality on a site-by-site basis, and to assist in keeping the study team on track
One of the true tests of leadership is the ability to recognise a problem before you need to find a remedy
Kenny Diricks, Founding CEO & Sr. Clinical Research Consultant
PEOPLE
Kenny Diricks
Sr. Clinical Research Consultant
Chief Executive Officer
Experienced Freelance Sr. Clinical Research Consultant with therapeutic knowledge in several medical domains, with a substantial background in the medical, clinical and scientific fields through his Master in physical therapy.
Good knowledge of MS Office applications i.e. Word, Excel, PowerPoint and Outlook. Experience with SPSS, Teams, IMPACT, Veeva Vault, iMedidata RAVE, Inform, Pubmed – Medline and Windows based OS. In general, very computer literate.
Specialties:
Cardiology/Vascular Diseases, Dermatology, Devices, Digestive, Endocrinology/Metabolic Diseases, Genitourinary, Hematology/Oncology, Infectious/virologic/Parasitic Diseases:, Musculoskeletal, Nervous System, Ophthalmology, Rare/Genetic diseases/Disorders, Respiratory and vaccinology.
PARTNER WITH US
We are dedicated to identifying partners who share our mission to provide outstanding quality, on-time delivery, and exceptional customer service to our clinical research partners.
At Seléos Solutions, innovation extends beyond our excisting programs to partnerships in which we engage. We look forward to learning more about your opportunity and discussing how we can partner with you.
Please submit any questions, suggestions, or general feedback in the space below along with your name and email address. We’ll get back to you within 24 hours. For specific enquiries about custom services or resourcing needs, please contact us at kenny@seléossoltions.com