Comprehensive
Clinical Trial Services Include:
- Study design & protocol development
- Patient identification and site engagement
- Site management and monitoring
- Third-party vendor management
- Biostatistics
- Data management
- Clinical Flow Cytometry
- Pharmacovigilance
- Medical monitoring
- eTMF management
- Quality Assurance
TRIAL MANAGEMENT
Unmatched clinical trial management every step of the way.
Through every research milestone and phase, our experienced project managers and oncology drug development experts will keep your trial on a successful path. TD2’s integrated team can manage all aspects of your study from trial design and feasibility, site selection and management, project management and monitoring, to data management, biostatistics and report writing.
A detailed communication plan is developed up front to keep you informed through regular meetings, status reports and timely responses. Thoughtful data analysis strategies are customized for your trial to guide the decision-making process and inform your clinical development strategy. Through consistent documenting, tracking and comprehensive risk management, we can anticipate roadblocks, identify new opportunities in real-time and shift plans as needed to maximize the success of your program.
Identifying the Right Patients
Leveraging artificial intelligence through expansive, real-time databases, we can select the right patient for your clinical trial. Not only can we identify potentially eligible patients using protocol-specific inclusion and exclusion criteria, we can also alert the patients’ treating physician for faster matching with your clinical trial.
PROGRAM ANALYSIS
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.
MEDICAL WRITING
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
