For pharmaceutical (drug) studies MedApex Research provides clinical trial execution strategies and support to help your company determine the optimal investigator sites, therapeutic area and patient access based on the product and at each stage of clinical development for a New Drug Application (NDA), Investigational New Drug (IND), or Biologics License Application (BLA).
Preclinical studies:
● Full management of preclinical trials, including animal studies and laboratory testing to evaluate safety, efficacy, and optimal dosing.
● Data analysis and submission of preclinical results as part of the FDA regulatory submission process.
Clinical Trial Phases for Pharmaceuticals
● Phase I clinical trials:
■ First-in-human trials designed to assess safety, dosage ranges, and pharmacokinetics.
■ Expert oversight to ensure compliance with Good Clinical Practice (GCP) guidelines.
● Phase Ib-IIa:
■ Proof of concept efficacy and safety clinical trials
● Phase IIb-II
■ Early efficacy studies focusing on specific patient populations, determining the therapeutic benefits and side effects.
■ Adaptive trial designs and patient monitoring for better trial outcomes.
● Phase III
■ Large-scale trials to confirm efficacy and monitor adverse reactions (pivotal clinical trials).
■ Statistical data collection and analysis, with real-time monitoring for safety and effectiveness.
● Phase IV – postmarking clinical trials
■ Long-term follow-up studies post-approval to monitor safety in a larger population.
■ Pharmacovigilance services to ensure ongoing compliance with FDA safety standards.
MedApex Research will provide the key duties and responsibilities in Phase I-IV FDA drug development
● Site selection and feasibility – within and outside of our clinical trial site network, we will evaluate and select the clinical trial site based on multiple factors such as investigator expertise, patient population and previous performance.
● Patient recruitment and retention - design and implement strategies to recruit patients, ensuring that the target population is reached effectively, develop plans to maintain patient engagement and compliance throughout the trial, minimizing dropouts and ensuring a sufficient sample size.
● Manage all start-up activities – to ensure that all trial activities follow GCP guidelines and FDA regulations, conduct regular on-site and remote monitoring, ensure that any safety concerns or AE/SAEs are addressed and reported immediately.
● Data Collection and Management - ensure high-quality data collection including the use of electronic data capture (EDC) systems, regularly verify that data entered into the trial databases matches source documents at the clinical sites.
● Regulatory Compliance and Reporting - prepare and submit required regulatory documentation, act as the liaison between the sponsor and the FDA, prepare trial sites for FDA inspections and internal audits.
● Statistical Analysis and Reporting - Design the statistical analysis plan (SAP), determining how the trial data will be analyzed to ensure robust and valid results, prepare the clinical study report (CSR) summarizing the trial's findings.
● Post-Trial Responsibilities - monitor the safety and efficacy of the drug after FDA approval which includes pharmacovigilance, adverse event monitoring, and compliance with FDA post-marketing requirements.