Your oncology treatment’s success starts with the right partner. As a full-service oncology CRO, we offer an extensive portfolio of program analysis and strategic consulting, medical writing and start to finish clinical trial management. We focus on individualized patient recruitment and advanced technology to make sure the right patients are enrolled in trials best suited for them. Our dedicated project managers will work with you every step of the way through each phase, positioning your therapy for success.
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.
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.
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).
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.
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.
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.
CT26 SC tumors: Gating strategy T cells and NK cells.
Gating involved identifying the total cell population, and then gate out the doublets, gate out the dead cells, move on to our first marker CD45 which gates out any non-immune cells. The bottom right cytogram shows the different NK cell populations. The far left middle cytogram depicts the two T cell population CD4+ and CD8+. Values are % of total CD45+ cells.
Screening tools for the evaluation of a drug’s ability to cross various biological membrane systems in a microplate format.
Figure 7. Example of Caco-2 Assay results. Assessment of the permeability of either Metoprolol (highly Permeable) or Quinidine (PgP substrate). A cell monolayer grown on a filtered-well is used to evaluate test compound movement between the insert (apical compartment -A) and the plate well (basal compartment -B). Passive transport through the layer is determine by A-B flux, whereas active transporter will introduce a B-A distribution of compounds between the two compartments.
In vitro drug metabolism studies, are a screening mechanism to characterize drug metabolites, elucidate their pathways, to help with further in vivo testing.
Figure 5. Observes relationship between inhibitor
(Ketoconazole) and the substrate (Midazolam).
Figure 6. Inhibition Profile for CYP3A4
Protein binding assays assesses the degree to which drugs attaches to proteins within the plasma/tissue. A drug’s efficacy may be affected by the degree to which it binds. TD2 has validated this assay using the Rapid Equilibrium Device and analysis done by LC-MS.
Figure 3. The process of protein binding assessment with rapid equilibrium dialysis.
Figure 4. Protein binding analysis by equilibrium dialysis of plasma
across mutiple different speacies (mouse, rat, dog, monkely, human)
following exposure to multiple compounds.