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.