Sponsors
DELPHINIUM expertise in Phase I Clinical Studies
The DELPHINIUM team has deep expertise in conducting early-phase clinical trials, offering the complete range of Phase I studies. We understand that early phase development requires a highly coordinated effort to adhere to timelines, deliver excellent quality data and anticipate to possible challenges. We deliver studies that form the foundation for your later-stage clinical success.
We offer personalized support to each client, adapting our approach to meet the unique goals and requirements of your research, whether you are new to clinical trials or have extensive experience.
We design and execute a variety of Phase I study types in healthy volunteers, including:
First-in-Human (FIH) Studies: We carefully guide our clients through their first-in- human studies, using comprehensive safety and pharmacokinetic assessments to set the foundation for successful drug development. We implement flexible, adaptive designs that allow for modifications based on interim results, helping clients make data-driven decisions that enhance study efficiency and success rates.
Single and Multiple Ascending Dose (SAD/MAD) Studies: These studies help establish the safety, tolerability, and pharmacokinetics of new drugs over single or repeated doses.
Drug-Drug Interaction (DDI) Studies: Our team evaluates how new investigational drugs interact with other therapies to optimize dosing regimens and predict potential interactions early in development.
Food Effect Studies: These studies examine how food intake influences drug absorption and efficacy, ensuring clear dosing instructions are provided to patients. Our clinic offers standardized meals, including those meeting FDA requirements for Food Effect studies
Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: By integrating PK and PD assessments, we provide comprehensive insights into drug behavior, linking drug concentration to therapeutic and biological effects. We collaborate with selected vendors who are leaders in the field, ensuring precise correlation between drug concentration and therapeutic effects. This approach enables us to offer comprehensive PK/PD analysis to inform dose selection and efficacy evaluation.
Bioavailability and Bioequivalence (BA/BE) Studies: We evaluate how different formulations of the same drug compare in terms of absorption and activity, supporting regulatory requirements and formulation development.
Thorough QT/QTc Studies: We partner with highly specialized vendors who bring extensive expertise in conducting thorough QT/QTc studies, ensuring accurate assessment of a drug’s impact on cardiac safety. These collaborations allow us to provide reliable and robust QT/QTc evaluations, supporting our clients’ safety assessments. With a small, dedicated team and direct communication lines, we offer the flexibility and responsiveness needed to adapt to evolving client needs. Our partnerships with trusted vendors and our pragmatic, client-centric approach ensures the successful execution of each study, enabling our clients to advance their clinical programs with confidence and speed. Throughout each phase, we provide tailored guidance and advice on the most suitable clinical development path for your drug, helping you make informed decisions that align with your program’s goals.
