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

Late Phase Clinical Trials | Techsol Life Sciences

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.

Argus Consulting Services | Techsol

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.

Business Meeting

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.

Medical Review

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.

Business Discussion

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. 

Clinical Investigation & Evaluation | Techsol Life Sciences

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.

Real World Evidence

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:

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.