Clinical Trials Services

• Protocol Development: Designing trial protocols tailored to study objectives, regulatory requirements, and therapeutic areas.
• Regulatory Submissions: Preparing and submitting Investigational New Drug (IND) applications and obtaining Ethics Committee/IRB approvals.
• Feasibility Studies: Assessing the viability of the trial in terms of patient recruitment, site selection, and resource allocation.

First-in-Human (FIH) Studies :

• Managing initial studies in humans to determine safety and dosing.

Dose Escalation Studies:

• Conducting single ascending dose (SAD) and multiple ascending dose (MAD) studies.

Bioavailability/Bioequivalence (BA/BE) Studies:

• Evaluating drug absorption and formulation performance.

PK/PD Studies:

• Characterizing the drug’s absorption, distribution, metabolism, excretion (ADME), and effect on biomarkers.

Recruitment and Retention:

• Strategies for enrolling healthy volunteers or patient populations quickly and effectively.

Site Management:

• Supporting clinical trial sites with training, monitoring, and resources to ensure compliance and data quality.

Specialized Testing:

• Advanced biomarker and genetic testing to refine study results.

Modeling and Simulation:

• Predicting human responses using computational models based on preclinical data.

• Electronic Data Capture (EDC): Implementing systems to ensure accurate, real-time data collection.
• Statistical Analysis: Designing and executing analyses to evaluate trial results.
• Safety Reporting: Ongoing monitoring and reporting of adverse events (AEs) and serious adverse events (SAEs).

• Phase 0 Trials (Microdosing Studies): Gathering early PK data with minimal drug exposure.
• Translational Research: Bridging preclinical findings with clinical data to optimize dosing and therapeutic strategies.

• Ensuring compliance with Good Clinical Practice (GCP) and local regulations.
• Liaising with regulatory agencies for expedited approval pathways (e.g., orphan drugs, breakthrough therapy designations).

• Bioanalysis: Providing laboratory services for PK/PD samples.
• Early Patient Studies: For niche areas like rare diseases or oncology, CROs often handle early patient-based trials instead of just healthy volunteers.

Protocol Development:

• Designing study protocols to address regulatory, commercial, and scientific objectives.

Feasibility Studies:

• Assessing site capabilities, patient recruitment potential, and regional considerations.

Regulatory Strategy:

• Ensuring compliance with regulatory requirements for approval and post-marketing obligations.

Project Management:

• Coordinating multidisciplinary teams, timelines, and budgets.

Site Management:

• Managing investigator sites for large-scale studies, including training and compliance.

Patient Recruitment and Retention:

• Employing strategies to enroll and retain diverse populations effectively.

Clinical Monitoring:

• On-site and remote monitoring to ensure protocol adherence and data integrity.

Real-World Evidence (RWE) Collection:

• Leveraging observational studies, registries, and electronic health records.

Risk-Based Monitoring (RBM):

• Using data analytics to prioritize monitoring efforts.

Data Collection Platforms:

• Using electronic data capture (EDC) systems for real-time data access.

Data Cleaning and Validation:

• Ensuring accuracy and completeness of collected data.

Statistical Analysis:

• Performing advanced biostatistical analyses to support study endpoints.

Adverse Event Reporting:

• Tracking and reporting safety data per regulatory guidelines.

Risk Management Plans:

• Developing and implementing strategies to manage identified risks.

Periodic Safety Updates:

• Preparing safety reports for regulatory submissions.

Submission Support:

• Preparing dossiers for regulatory authorities (e.g., FDA, EMA, PMDA).

Communication with Authorities:

• Acting as a liaison for regulatory queries and audits.

Post-Approval Support:

• Ensuring compliance with ongoing regulatory requirements.

Health Economics and Outcomes Research (HEOR):

• Demonstrating the economic value of the product.

Payer Engagement:

• Supporting reimbursement and market access strategies.

Real-World Evidence Studies:

• Generating evidence to support long-term use and market positioning.

eCOA and Wearables:

• Leveraging technology for patient-reported outcomes and remote monitoring.

AI and Data Analytics:

• Enhancing insights from study data for decision-making.