Your partner in oncology

Contact

OTD
Oncology Therapeutic Development

100 rue Martre
92110 Clichy - FRANCE
Tel:  +33 1 47 15 01 01
Fax: +33 1 45 19 06 59

Contact Us

Clinical

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)