Clinical Study Management

Innovative Clinical Trials Today. Impacting Cancer Tomorrow.

Clinical trial support you can rely on.

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.

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.

Our full scope of clinical trial services includes:

  • Study design & protocol development
  • Feasibility and site-selection
  • Site management and monitoring
  • Third-party vendor management
  • Biostatistics
  • Data management
  • Pharmacovigilance
  • Medical monitoring
  • eTMF management
  • Quality Assurance
  • Study design & protocol development
  • Feasibility and site-selection
  • Site management and monitoring
  • Third-party vendor management
  • Biostatistics
  • Data management
  • Pharmacovigilance
  • Medical monitoring
  • eTMF management
  • Quality Assurance

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). 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.

Our full portfolio of medical writing services includes:

  • 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

Contact Us

Put your clinical trial in the hands of a team who believes in your research as much as you do.

Move your research forward, smarter.

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