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Oncology Trial Management

Biotrial is a global CRO with over 35 years of experience in oncology trial management.

We are committed to advancing oncology research and will offer tailored CRO services and solutions to support the development of cancer drugs and medical devices. Our team collaborates closely with sponsors to optimize study design and implement innovative technology for patient monitoring and safety throughout the study phases.

Biotrial-clinical-oncology-trial-management

Our added values

Experience: We have conducted hundreds of early-phase oncology studies in a wide range of therapeutic areas.
Expertise: Our team of oncologists, clinical trialists, and data analysts are experts in the field of cancer research.
Collaboration: We work closely with oncology KOLs to ensure that our trials are designed and conducted to the highest standards.
Regulatory compliance: We comply with all applicable regulations and good practices, including those from the FDA, the EMA, and other regulatory agencies.
Quality assurance: We have a robust quality assurance program and processes in place to ensure the quality of our work.
Communication: We practice efficient and effective communication with transparency with our sponsors.
Flexibility: As a medium-sized CRO, we have the flexibility to adapt to the changing needs of sponsors and patients

We work on many different study designs, including Phase I/II beginning, with a drug dose escalation phase to determine the Recommended Phase II Dose – which is then used in the expansion phase in larger patient cohorts.

Access to Patients & sites

At Biotrial, we understand that access to patients and the right site is essential for the success of an oncology clinical study project. We will help you Identify and recruit eligible patients and sites that are willing to participate, monitor results, and report with transparency.

Our partners in the US and Europe include:

Consultants
Key Opinion Leaders (KOLs)
Expert investigators
Cancer institutes
Hospitals
Clinics

Expertise

early phase Experience

Team expertise

Phase I/II, FIH studies in Healthy Volunteers and patients
TQT, DDI, Food Interactions & PK/PD studies
Patient-centric approach
Experience in safety assessments
End-to-end services

In-house oncologist
Experienced professionals trained in the latest oncology designs & endpoints
CRAs/CPMs annually trained on oncology practices based in France and the USA
Network of oncologists, for solid and liquid tumors

Therapies

Biotrial offers a comprehensive range of oncology therapies, including:

Targeted therapy (small molecules & biologics)
Chemotherapy
Hormone therapy
Immunotherapy (checkpoint inhibitors, MABs, vaccines, T-cell therapy,…)
Stem cell therapy
Radiation therapy
Medical device
Cancer supportive care medication (analgesia, anemia, emesis, cachexia,…)

Indications

Cancer research can be an extensive process, and it’s vital to partner with a CRO company with the right experience and knowledge.

At Biotrial, we have extensive experience conducting clinical trials for a variety of solid tumors, including breast cancer, lung cancer, and colorectal cancer as well as a a strong track record of success in trials for hematological malignancies, such as leukemia and lymphoma.

areas of Indication expertise include:

Brain cancer: including glioblastoma and medulloblastoma.
Lymph node cancer: including Hodgkin lymphoma and non-Hodgkin lymphoma.
Lung cancer
Kidney cancer
Liver cancer

Prostate cancer
Ovarian cancer
Skin cancer: including melanoma and squamous cell carcinoma.
Pancreas cancer
Colon cancer

Time & Cost efficiency

Biotrial understands the importance of time and cost in early-phase oncology trials. We aim to help each biotech and pharmaceutical sponsor accelerate the development of oncology therapies and advance medical solutions for cancer patients while we work to ensure the quality and precision of the trial data.

Regulatory compliance

The FDA, the EMA, and other agencies have strict regulations in place to ensure the safety and efficacy of new cancer drugs, which life science companies must comply with to protect patients and ensure data precision and integrity.

Some of the key requirements that Biotrial’s staff are trained in and practice include:

Data safety monitoring (DSMB): must be established to oversee the safety of patients in a clinical trial. The DSMB reviews data from the trial regularly and can recommend that the trial be stopped if there is a safety concern.
Inspections: Agencies will inspect clinical trial sites to ensure that they comply. CROs must be prepared to undergo inspections and to provide documentation to support good practices and compliance with regulations.

Biotrial ensures each internal process complies with all applicable regulations and follows guidelines set in place, Helping to protect the safety and efficacy of each new drug and treatment

Resources

A Phase I/II study administered in combination with immunotherapy to patients with advanced solid tumors

Hemato A Phase 1 dose escalation and expansion study in patients with previously treated relapsed or refractory multiple myeloma

An Open-Label Multicenter Phase 1 Study in Subjects With Selected Advanced Malignancies

Related Information

Specialized Phase I studies Phase I Healthy Volunteers Patient Trial Management Clinical Monitoring Pharmacovigilance & Medical Monitoring Pharmaceutical Affairs Regulatory Affairs