As specialized clinical operations professionals, we have experience in all development phases (Phase I-IV) and a diverse range of pharmacological modalities and therapies.
We have expertise in innovative cancer treatments and substantial experience in numerous therapeutic areas.
Our extensive experience in clinical trial management and business projects has provided us with broad hands-on experience with a wide variety of immunotherapies, antibodies, immune checkpoint inhibitors, and cell and gene therapies.
We have demonstrated expertise in the early phase but also in the late stage setting. Many of our previous experiences include first-in-human Phase I/II trials, with a dose-escalation trial design and/or other multifaceted procedures or adaptive trial designs.
Beyond our experience in Early phase trials, we have substantial experience in conducting late phase and pivotal clinical research management studies. We understand how many hurdles can be encountered during the critical route toward marketing approval.
We have a comprehensive understanding of what the requirements are from both the pharma and biotech sides.
We have expertise with innovative cancer treatments and have substantial experience in antibodies, as well as chemotherapies and small molecules in the Oncology setting.
We can act as your Program Leader, your ClinOps strategist, and your Clinical Trial Management partner and provide you with the support you need to oversee your clinical programs, as well as your CRO and vendor activities.
Our philosophy and values are based on leadership. When it comes to clinical trial management—experience counts. We have significant experience planning, implementing, and managing all phases of clinical trials, even complex ones in multiple therapeutic areas.
We customize our approach to each project, drawing on our years of experience to provide the optimal solution to each client’s needs and challenges. Flexibility and transparency are key to that success.
We have a broad knowledge of clinical research and clinical development methodology and processes.
We provide outstanding organizational and analytical skills with exceptional interpersonal skills, professional demeanor, thought leadership, flexibility, and the ability to handle the uncertainties associated with a fast-paced environment.
Equipped with strong ability to problem solve, prioritize, negotiate and juggle changing deadlines.
We have a unique ability to bring teams together to collaborate with multiple departments while maintaining tact and diplomacy.
To be succesfull we must employ outstanding project management and organization skills with the ability to effectively deal with ambiguity and handle politically sensitive and confidential information.