Oncology Clinical trials Management
The unique patient populations, study design challenges, and special endpoints associated with oncology trials demand specialized knowledge. inVentiv Health Clinical's Oncology team is uniquely qualified to manage that complexity. Our experience spans many indications, interventions, and phases of oncology drug development. We apply our therapeutic expertise to address the unique challenges of oncology research - and help get critically needed products to market faster.
Our team includes board-certified oncologist and hematologists. Our therapeutically focused CRAs and project managers average five or more years of clinical experience, and their therapeutic alignment gives them unique oncology knowledge.
We have the global capabilities to facilitate study startup and execution around the world, with access to more than 600 oncology professionals worldwide. Our flexible service can accommodate both highly specialized Phase I studies in oncology patients and large-scale, global Phase III trials. From international regulatory submissions to patient recruitment, we understand the clinical and geographic aspects of global oncology research.
Category Experience and Capabilities
inVentiv Health Clinical has experience that spans the spectrum of oncology indications. This includes working on studies in all research phases, focusing on targeted therapies (alone or in combination with chemotherapy), chemotherapy, radiopharmaceuticals, in vivo diagnostics, and supportive care. Our clinical experience includes trials in oncology patients across all investigative phases (I-IV) at more than 13, 000 sites globally, targeting the enrollment of more than 90, 000 oncology patients in the last five years.
If you require specific assistance with your oncology studies in the areas of data services (data management, biostatistics, and medical writing) or pharmacovigilance, we can provide therapeutically focused stand-alone services. Members of inVentiv Health Clinical's Oncology team, including its CRAs, routinely utilize RECIST criteria for tumor assessment and NCI Common Toxicity Criteria. The team also has significant experience in the development and management of data safety monitoring boards (DSMBs). We can also assist companies when a compound is ready for the transition from the preclinical lab to its first Phase I study in humans.
Expanded Access, Patient Registries
In addition to managing Phase I-III programs, we also have experience with late stage trials, including oncology expanded access and patient registry studies. Our in-depth understanding of what's involved in these programs enables us to plan, launch, and run them efficiently. At every point, we work to balance the needs of the investigative sites with the needs of the sponsor.
- Leukemias: ALL, AML, CLL, CML
- Lymphomas: Hodgkin's & non-Hodgkin's
- Multiple myeloma
- Myelodysplasticsyndrom (MDS)
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.
How clinical trial managers can improve organizational efficiency without affecting quality
Steps required to make an environment (processes, organizational structure, and IT systems) that lets the enhanced operations. Clinical trials are complex and expensive, and are made complex and expensive by the processes and technologies which a clinical team has to follow.