SMS-oncology is a full-service CRO specialised in clinical drug development studies in oncology and hemato-oncology. From the initiation and implementation to the completion of phase I to IV oncology clinical trials, we are able to provide you with the complete range of clinical trial services you may need for your oncology studies. Moreover, we provide strategic oncology drug development planning and expert advice, as we understand the challenges of developing anti-cancer drugs in the highly competitive oncology market. We are specialised in the execution of early-phase oncology and immuno-oncology trials throughout (Western) Europe.

The 4D oncology CRO

We’re unique in that we use our oncology expertise to provide direction to sponsors along the path of drug to data to dossier ("4D"). This is done by giving strategic advice before the study and turning complex data into meaningful insights during the study. This helps sponsors to make informed decisions, identify opportunities and drive risk-mitigated studies. In other words, SMS-oncology adds an extra dimension to clinical cancer research by providing direction to our sponsors.

Clinical CRO services, a tailor-made solution

The strength of our business model, providing direction along the drug – data – dossier path, is that we integrate our strategic oncology drug development planning and expert advice with clinical operations during the initiation, implementation and completion of oncology clinical trials.

SMS-oncology is flexible towards the needs of sponsors. We take pride in customising our services to your needs and delivering a variety of tailor-made services, summarised as clinical operations, consultancy and integrated services.

Clinical operations

Our full range of clinical trial services includes:

  • site and investigator selection
  • medical writing
  • regulatory submissions
  • site management and project management
  • site visits
  • pharmacovigilance
  • biometrics.

We work with responsive and "right-sized" project teams, ensuring close collaboration, flexibility and fast decision-making. The close and personal involvement of the management team ensures hands-on operational services with high quality standards.
We are specialised in early-phase and immunotherapy oncology trials.

Early-phase oncology trials are all about demonstrating proof of concept: efficacy with acceptable toxicity. During early-stage clinical development, oncology "know-how" is of key importance. Detailed data is collected in a limited number of specialised sites led by experienced investigators. Due to the complex nature of early stage studies, our clinical projects are monitored intensively by oncology-trained CRAs and closely managed by our experienced project managers.

SMS-oncology is at the forefront of working with innovative cancer treatments including immunotherapy. We have an in-depth knowledge of the modes of action of the different types of immuno-oncology drugs (e.g. DC vaccines, immune-stimulating peptides) as well as hands-on experience of the execution of immuno-oncology trials.


Our consultancy team helps sponsors to overcome the challenges of developing anti-cancer drugs and uncover potential opportunities by providing expert advice. Whether it is strategic advice to underpin the client’s drug development path − including elements such as medical science and medical affairs expertise related to clinical trial design and accompanying translational study plans as well as technical expertise in planning and project management − we can think with you to discover the full potential of your oncology drug. We are true oncology specialists in thinking, processes, attitude and people.

Integrated services

We are able to team up with biotech companies at (late) preclinical development and provide strategic support by assisting them with the creation of the clinical development plans and trial designs. Our advice can be directly translated into clinical operations resulting in a seamless transition from the drawing board to the clinic. During a clinical study, a large amount of data points are collected. Using our oncology expertise we can turn this often complex data into meaningful insights. This is done on an ongoing basis during the conduct of the study and reported to the sponsor at regular intervals.

Oncology trials ask for oncology experts

Our knowledge and expertise have been acquired through our longstanding hands-on experience in oncology clinical trials and product development, involving a broad range of indications as well as numerous and diverse therapeutic modalities. Since our founding in 2007, we have served over 65 clients from small biotech to big pharmaceutical companies, of which many return for continuing collaboration.

Contact details

Interested in knowing how we could provide direction to your oncology drug development? Please contact a member of our Business Development team, or use the form below to send us your business enquiry.