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Clinical operations

Clinical operationsOncology trials require oncology experts. Our knowledge and expertise has been acquired through longstanding hands-on experience in oncology clinical trials and product development covering a broad range of therapies and tumor types. Besides our specialization in early phase trials, we are experienced in conducting late phase trials, pivotal trials, post-marketing trials and compassionate use/early access programs.

Central to the success of  clinical operations is the strength of our capabilities, systems and processes:

"In the name of my study team in Essen I would like to send you a very positive feedback from the initiation visit of our study we had today. The SMS-oncology CRA gave an excellent overview and all important information of the study: She was brilliant! She had a very good specialised knowledge, gave a focused and great presentation, and had very good problem orientated communication skills… It was a pleasure to have her visiting our site today!”

     - Dr. Beate Wulff, Head Early Phase Trials & Senior Paediatric Haematologist/Oncologist at Universitätsklinikum Essen, Germany

Project management

A well-managed project is one whose team members are well trained and which is carried out per contract and within budget. But there is more, as a successful outcome lies in careful thinking and up-front planning of all key aspects of a clinical trial.

SMS-oncology works with devoted and flexible project teams that can make quick decisions and works closely with the sponsor, as well as with third parties. This allows us to identify challenges early and proactively address them in a joint effort to reaching sponsors’ goals and milestones.

Our sponsors benefit from our project management expertise as we:

  • Ensure a full understanding of the trial and alignment of the project with the sponsor program goals and implement a strategy to meet targets and timelines
  • Put together a comprehensive team, provide sufficient resources and clearly define roles, task ownership and responsibilities
  • Write detailed project plans that describe all key activities within the clinical trial, so that clear instructions on how the job will be done are available for all stakeholders
  • Mitigate risks associated with key challenges in the trial such as site selection, patient enrolment, safety monitoring and data collection
  • Optimize quality and ensure a timely and accurate objective confirmation of the study endpoints
  • Use project reporting tools which provide useful study metrics and allow for early detection of trends and signals in the data
Site and investigator selection

From our centralized location directly next to Amsterdam Airport Schiphol, SMS-oncology is ideally situated to conduct clinical trials throughout Europe. Our local CRA staff can easily and directly liaise with our extensive network of Key Opinion Leaders (KOLs) and investigators at renowned oncology centers, academic institutes as well as regional hospitals to select the most suitable sites and investigators matching your specific requirements of the trial, phase, and product.

We have conducted trials in over 150 sites and more than 20 countries.

Site management and monitoring

The monitoring of oncology trials is more complex compared to other therapeutic areas due to the severity of the disease and the recruitment of advanced, heavily pre-treated patients. Clinical Research Associates (CRAs) in the field of oncology require specific skills and expertise. Working exclusively with dedicated, oncology experienced and local CRAs is one of the hallmarks of our company.

Beyond performing monitoring activities and site visits, site management is of key importance. Our CRAs maintain close and frequent contact with the sites to be up-to-date with the site activities and to proactively address any questions or concerns, provide logistical and day-to-day support. We believe in maintaining good relations with site personnel through open communication with them throughout the study, as this helps reaching the First Patient In (FPI) milestone and patient recruitment in general.

Our oncology CRAs:

  • Proactively ensure all study procedures are performed as defined by the protocol
  • Train sites on “best practices” for patient recruitment and retention
  • Are well-versed in monitoring to verify ICH-GCP compliance as well as in oncology specific monitoring and tumor specific evaluation criteria and immune-related criteria (e.g. RECIST 1.1, RANO, irRC and iRECIST)
  • Carry out full Source Data Verification (SDV) at sites, supported by in-between remote monitoring
  • Identify, anticipate, and help resolve all scientific, regulatory and logistical site issues
  • Assist with data query resolution and SAE reconciliation
  • Are exceptionally skilled in risk based monitoring (RBM)

Cases studies

RFP or protocol advice?

Would you like to request a proposal (RFP), or interested in getting a free and confidential review of your planned early phase oncology trial (draft) protocol? Use the forms below:

Request for expert protocol advice (free) Request for proposal