Clinical oncology
OUR EXPERIENCE
The OTD team (composed of MD, PhD or MSc) has collective experience managing over 60 worldwide Phase I-II oncology clinical trials, including several first-in-man molecules. We have solid international experience collaborating with small biotech companies, mid-size and large pharmaceutical organizations, academic institutions, CROs and a wide selection of hospitals and clinics, contributing to an extensive international network. Our collective strength lies in our diverse backgrounds, extensive oncology experience and high-level training.
As a small and flexible boutique CRO, we:
- Tailor our activity to match the needs of small biotechs ensuring personalized study implementation
- Ensure reactivity
- Promote direct communication between our oncologists and study PIs
TUMOR TYPES AND THERAPIES
Solid tumors: Bladder, breast, cholangiocarcinoma, colorectal, glioblastoma, head & neck, hepatoma, lung, melanoma, ovary, pancreatic, prosate, renal, sarcomas, stomach, thyroid, and rare tumor types (eg, NMC)
Hematologic malignancies: leukemia (ALL, AML), Hodgkin’s and non-Hodgkin’s lymphomas, β-hemoglobinopathies (SCA and β-thalassemia major), myeloproliferative disorders
Monotherapy/Combinations: classic cytotoxics, targeted therapeutic agents (small molecules and monoclonal antibodies), hormonal therapies, cell-based therapies, vaccines
OUR services
We manage all or selected aspects of phase I/II oncology clinical trials, from protocol conception through to study report writing:
- Study design, target population definition, drug combination optimization
- Protocol, amendment and informed consent writing
- eCRF design emphasizing clinically-relevant data
- Regulatory package preparation and submission to health authorities and ethics committees/IRBs
- Patient eligibility verification
- Project management
- Site selection (PSV) and management
- Monitoring
- SAE medical safety monitoring
- Pharmacokinetic/pharmacodynamics management and analyses
- Data management (eCRF)
- Statistical analyses and randomization (IVRS)
- Medical writing: CSR (ICH E3 compliant), SAE narratives, posters, abstracts and peer-reviewed manuscripts
- Pharmacovigilance: database, SAE management, electronic transmission of SUSARs (EMA certification / Eudravigilance)
