The depth to innovate, the science and scale to accelerate
We bring deep science to bear. Our integrated team will design a personalized approach, then generate robust scientific information to support dose selection, characterization of mechanism of action, and patient selection/stratification—ultimately reducing time to approval and increasing the value of your drug by bolstering the scientific understanding of the product.
We consider every pressure point. It’s not enough to address clinical trial issues—so through every phase of the developmental pathway we use our unique in-house expertise to probe the scientific, regulatory, and commercial factors that will shape the program and define its goals, and to develop proactively an effective risk-mitigation strategy.
We focus on market access from the start. The most successful clinical development plan may sacrifice value if it ignores commercial realities or fails to develop the evidence needed to maximize market access. That’s why we analyze market access considerations, then overlay them for target positioning and trial design.
Study Startup: Our exclusive Oncology Site Network comprises global community and academic centers, each with the critical capabilities necessary for predictable, consistent startup and enrollment of precision medicine oncology trials. In rare disease—where patient enrollment is a critical challenge—our deep connections with patient advocacy groups and key opinion leaders help speed recruitment and hasten startup.
Study Monitoring: Precision clinical research associates (CRAs) are site ambassadors, and our model for clinical monitoring provides the framework to make this possible. Our CRAs are assigned to a trial based on their experience, relative to the tumor type or rare disease area and trial design, and focus exclusively on 1–2 trials at a time. Precision CRAs are the key point of contact for all site monitoring and study logistics.
Project Management: Our studywide PMs are experienced in collaborating across translational science and clinical operations, working closely with each site to deliver real-time, quality biomarker and clinical endpoint data that support rapid, informed decision-making.
Study Quality: We start by building quality into all of our SOPs—then have executives conduct quality reviews of every deliverable, every week, supplemented by quarterly review board meetings with the project teams and sponsors.
Medical Monitoring: Our in-house team consists of licensed and board-certified physicians—all experienced in clinical research, all knowledgeable about numerous oncology indications and various types of rare disease. They know our processes; they know your disease state; they know how to keep your trial on track.
Data Management: Our full-service, independent data management operations work cross-functionally to ensure we deliver quality clinical data as early in the data cycle as possible, reducing errors and increasing trial efficiencies. We harness key electronic data capture (EDC) systems: Oracle InForm™, Medidata, DataTrak, and Medrio.
Clinical Data Review: Custom programmed for each study, our proprietary Smart Patient Profile (SPP) provides a holistic, real-time view of each patient’s data with smart edit checks tailored to each protocol. This supports in-depth clinical data review via remote monitoring: Investigators and sponsors can quickly understand how patients respond to treatment; CRAs and the data review team can resolve queries and reduce time on site.
Clinical Biometrics: One of the industry’s most robust teams of clinical biostatisticians provides trial design consultation, statistical methodology recommendations, programming expertise, and data interpretation—delivering your trial results efficiently and on time. Senior-level statistical oversight, industry-standard SAS® software, and validation by an independent programmer reinforce quality control.
Regulatory Compliance: Oncology and rare disease create novel regulatory challenges. Our seasoned team is well-versed in global regulations, and works with you from the start to ensure your strategy is sound, your communications are clear, your data are correctly formatted—every potential barrier to success is removed.
Medical Writing: Using ICH-compliant templates, we deliver a range of documents from protocol development to clinical study reports, all developed per sponsor specifications, all thoroughly reviewed by our medical, statistical, and editorial teams.
Drug Safety: Our Safety Specialists are a team of registered nurses and healthcare professionals—uniformly experienced in oncology and rare disease—who provide full-service pharmacovigilance and safety surveillance over all protocols and events and use Oracle Argus™ for safety case processing.