Early Phase Clinical Studies
Early phase clinical studies in pharmaceutical research are designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug in human subjects. These studies are typically conducted after preclinical testing has shown promise in animal models and are intended to provide early insights into the safety and potential efficacy of a new drug candidate. The Phase I to Phase II clinical studies determine a medicinal product’s clinical relevance and commercial viability by primarily focussing on safety and efficacy.
Type of Studies We Support
- Phase I, First-in-human Studies
- Phase IIa, Proof-of-concept Studies
- Early medical device product development
- Pharmacokinetic and Pharmacodynamic (PK/PD) Studies
- Bioequivalence and biosimilar studies
- Ethnobridging studies
How We Can Help
At Techsol, our expert team of Clincial Research professionals have an extensive research background, scientific knowledge, and ample experience in successfully completing early phase clinical development programs for global pharma companies. We have strong capabilities to identify the right set of biomarkers, define suitable study design, and adopt patient-centric approaches to objectively evaluate drug safety, body’s response to the therapeutic intervention, monitor disease progression and the overall benefit-risk.
We provide the following functional services for assessing the safety, efficacy, and dosing of a drug and generating clinical and scientific evidence as per applicable regulatory guidelines.
Study Protocol Design and Study Plan Development
Assist in the development of study protocols, which are detailed plans outlining the objectives, design, and methods of a clinical study.
Site Selection, Initiation and Study Management
Identify, qualify and select suitable study sites and manage the day-to-day activities at the sites for the target clinical study.
Clinical Study Conduct & Site Monitoring
Coordinate with sites for begining patient screening with informed consent, study enrollment, IP dispensing, handling reported adverse events, and providing support throughout the study.
Regulatory Affairs & Medical Writing Support
Provide medical writing support to develop study essential documents and prepare clinical trial reports in the required format for regulatory submissions.
Data Management and Statistical Analysis
We can provide the right EDC solution along with our end-to-end clinical data management functional services to capture, clean and extract clean data sets for statistical analysis.
Patient Safety Monitoring & AE Reporting
Monitor patient safety during the study and report any adverse events to the relevant regulatory authorities.
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Common FAQs
PK (pharmacokinetics) and PD (pharmacodynamics) are critical components of drug development, and the statistical calculations used in early phase clinical studies are essential for assessing the safety, efficacy, and dosing of a drug. Some of the common PK/PD statistical calculations performed in early phase clinical studies are:
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Exposure-response analysis: This type of analysis evaluates the relationship between drug exposure (e.g., plasma concentration) and drug response (e.g., clinical efficacy, safety, or tolerability). The exposure-response analysis helps to identify the appropriate dose range and dosing regimen for further clinical development.
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Population PK modeling: This analysis estimates PK parameters (e.g., clearance, volume of distribution) in a population of patients, and can help identify factors that affect drug PK, such as age, gender, weight, and disease state.
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Non-compartmental PK analysis: This analysis calculates PK parameters (e.g., AUC, Cmax) using time-concentration data without making assumptions about drug distribution or elimination.
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Dose-exposure analysis: This analysis evaluates the relationship between drug dose and exposure, and helps to identify the dose range that produces the desired exposure.
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Safety analysis: This analysis evaluates the safety profile of the drug, including the incidence and severity of adverse events and the relationship between drug exposure and adverse events.
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Tolerability analysis: This analysis evaluates the tolerability profile of the drug, including the incidence and severity of treatment-related adverse events.
We have a stringent QMS to manage quality and compliance across all aspects of our clinical and data management operations. Our QMS has comprehensive policies, procedures, and controls to govern the entire clinical development process.