Expert analysis to keep your program on track.
A specialized team of oncology drug development experts advise every aspect of your program to keep your cancer treatment on track and accessible to those patients who need it most. Your comprehensive clinical plan starts early and includes a pre-IND strategy with a safety plan outlining toxicology, pharmacokinetics and pharmacology, bioanalytical as well as chemistry, manufacturing and controls (CMC).
Inform Decisions and Improve Outcomes
- Time on Treatment Analysis
- Data review on responders and patients benefit in advance of objective response
- Early detection of efficacy
- Biomarker and surrogate marker trends analyses
We excel in navigating the ever-changing regulatory landscape, including agency interactions and filing strategies based on current trends in oncology. Not to mention, clinical development and trial design strategies that include well-defined patient populations of interest based on your science and clinical opportunity. We thoroughly examine safety, feasibility of proposed dose, administration route, inclusion/exclusion criteria, “omic” profiles and biomarker strategies, as well as other special program requirements with future approval in mind.
Documentation specific to your trial’s needs.
TD2 provides a full suite of scientific and regulatory writing to address your program’s needs. Our team of medical writers and therapeutic experts work with you to develop documents in compliance with GCP and ICH guidelines. In addition to technical writing for all IND modules, we develop clinical trial protocols, Informed Consent Forms (ICF), Investigator’s Brochures (IB), Clinical Study Reports (CSR), as well as abstracts, manuscripts and more.
- Abstract and manuscript completion
- Drug development plans
- Investigator brochures
- Protocol synopses, full protocols and protocol amendments
- Informed Consent Form (ICF)
- Clinical study reports
- Interim data summaries
- FDA pre-IND meeting request and briefing packages
- Investigational new drug application (IND) (technical writing for all IND Modules 1-5)
- Abstracts and manuscripts
Put your clinical trial in the hands of a team who believes in your research as much as you do.
Are you ready to start your preclinical trial? Partner with a collaborative oncology CRO that believes in your treatment as much as you do. Take the first step today and contact our experts.