This white paper describes the methods and findings of a dose-escalation, open-label, pharmacokinetic, Phase I...
OTD is a CRO focused on oncology, specialised in the anticancer drugs.
OTD is a small and flexible team – our team is composed of MD, PhD or MSc) with a collective experience managing over 60 Phase I-II oncology clinical trials, and fully committed to quality and transparency.
The client benefit is to fully achieve the objectives and in the fastest possible time.
We provide the following services:
- Protocol Writing & e-CRF Design
- Regulatory Applications
- Project Management
- Data Management (preferred vendor)
- Report and Publications writing
OTD unique approach:
- Our Tactics: OTD’s medical oncologists closely review every patient “hands-on and in real-time”, while there is still time to address eligibility, toxicity and dosing issues.
- Special resources: Access to leading Principal Investigators and unique patient populations worldwide.
We have a specificity our experience in Phase I First-in Man managing clinically relevant information, analysis and transfer to Sponsor.
Tumour types and therapies
Solid tumours: Bladder, breast, cholangiocarcinoma, colorectal, glioblastoma, head & neck, hepatoma, lung, melanoma, ovary, pancreatic, prostate, renal, sarcomas, stomach, thyroid, and rare tumour types (eg, NMC)
Hematologic malignancies: leukaemia (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.
For more information on what OTD can offer you, please fill out the enquiry form attached to this page.
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