Early-Stage Clinical Trials
Collectively, our senior team have completed over 100 Phase 1 trials, in Australia, on behalf of US sponsors.
We understand the unique challenges associated with these early-stage studies, which focus on safety, tolerability, and occasionally preliminary efficacy. Critical data points we consider include pharmacokinetic (PK) and relevant pharmacodynamic (PD) measures, biomarkers, safety endpoints, and initial signs of clinical response.
We ensure rigorous and efficient trial execution by providing expert oversight on:
We have access to several FDA-audited Phase 1 CRUs and bioanalytical labs for analytical method development, validation and sample analysis.
Collectively, our senior team have completed over 100 Phase 1 trials, in Australia, on behalf of US sponsors.
We understand the unique challenges associated with these early-stage studies, which focus on safety, tolerability, and occasionally preliminary efficacy. Critical data points we consider include pharmacokinetic (PK) and relevant pharmacodynamic (PD) measures, biomarkers, safety endpoints, and initial signs of clinical response.
We ensure rigorous and efficient trial execution by providing expert oversight on:
We have access to several FDA-audited Phase 1 CRUs and bioanalytical labs for analytical method development, validation and sample analysis.
Pain points associated with early-stage clinical trials
- Limited Safety and Efficacy Data: In early-stage trials, there's limited data available on the safety and potential side effects of the investigational drug or treatment.
- Dose Determination: Determining the optimal dose that's both safe and effective can be tricky in the early stages without substantial prior data.
- Narrow Patient Population: Early-stage trials often focus on a very specific, sometimes rare, patient population which can make recruitment difficult.
- Biomarker Identification and Validation: Early-stage trials often involve the identification and validation of biomarkers for targeted therapies.
- Adaptive Trial Design and Protocol Amendments: Early-stage trials often require flexibility in design to respond to new data or unexpected results, leading to potential protocol amendments.
How iNGENū addresses these pain points
- Safety and Data: We employ advanced pharmacovigilance tools and monitoring systems, ensuring real-time tracking of any adverse events. By maintaining a transparent communication line with participants, we ensure early identification and management of potential safety concerns.
- Dose Determination: Using adaptive trial designs, iNGENū can adjust dosages based on interim results, ensuring the balance between efficacy and safety is optimized throughout the trial duration.
- Patient Population: Our recruitment strategies tap into niche patient networks, partnerships with specialty clinics, and patient advocacy groups to identify and engage the right participants promptly.
- Biomarker Identification and Validation: We employ cutting-edge technology to identify, validate, and monitor biomarkers, paving the way for personalized medicine approaches.
- Adaptive Trial Design and Protocol Amendments: iNGENū implements adaptive trial designs from the outset, anticipating potential shifts in the trial direction. Our streamlined processes ensure quick protocol amendments with minimal disruptions, maintaining the trial's integrity and timeline.