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

The OTD team has collective experience managing over 50 Phase I-II oncology clinical trials, including several first-in-man molecules.

Having collaborated with small biotech companies, mid-size and large pharmaceutical organizations, academic institutions and a wide selection of hospitals and clinics, our broad experience ensures an extensive international network.

 

Tumor types   

Solid tumors

Hematologic malignancies

Breast   
Thyroid
Ovary
Sarcoma
Lung
Pancreatic
Renal
Colorectal
Bladder
Melanoma
Stomach
Head & neck
Prostate
Glioblastoma
Hepatoma
Cholangiocarcinoma

Leukemia (ALL, AML)
Hodgkin’s and non-Hodgkin’s lymphomas
β-Hemoglobinopathies (SCA and β-thalassemia major)
Myeloproliferative disorders

 

 

THERAPIES (MONOTHERAPY AND COMBINATIONS)

  • Classic cytotoxics
  • Targeted therapeutic agents (small molecules and monoclonal antibodies)
  • Cell-based therapies
  • Vaccines
  • Hormonal therapies

 

We are specialized in the management of all aspects of phase I/II oncology clinical trials, from conception through to study report writing. We can manage all or selected aspects of your clinical trial:

  • Study design, target population definition, drug combination optimization
  • Protocol, amendment and informed consent writing
  • CRF design emphasizing clinically relevant data
  • Regulatory package preparation and submission to health authorities and ethics committees/IRBs
  • Patient eligibility verification
  • Project and site management
  • Monitoring
  • SAE medical safety monitoring
  • Pharmacokinetic and pharmacodynamics analyses
  • Data management (eCRF), randomization (IVRS), and statistical analyses
  • CSR writing (ICH E3 compliant), SAE narratives, posters, abstracts and peer-reviewed manuscripts
  • Pharmacovigilance: database, SAE management, electronic transmission of SUSARs (EMA certification / Eudravigilance)
  • Quality assurance