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Our Services

Clinical Research Solutions

Whether you need BA/BE studies for generic approvals or full-scale Phase III trials, our team handles the science, paperwork, and regulatory requirements.

Bioavailability and Bioequivalence (BA/BE)

BA/BE studies for generic drug approvals

We conduct BA/BE studies that help generic manufacturers prove their formulations work the same way as reference products in the human body.

Crossover studies in healthy volunteers under fasting conditions

Food-effect trials comparing fed versus fasting states

Calculation of AUC, Cmax, and Tmax from plasma concentration data

Preparation of study reports for ANDA submissions

Clinical Development Services

Phase I-IV trial management

From first-in-human studies to post-marketing surveillance, we manage trials that bring new medicines from lab bench to patient bedside.

Dose-escalation studies in Phase I to establish safety profiles

Multi-center trials coordinated across hospitals and research sites

On-site monitoring visits to verify source documents

Electronic data capture systems with built-in edit checks

Bioanalytical

Drug concentration analysis using LC-MS/MS

Our laboratory measures drug concentrations in blood samples using LC-MS/MS and other techniques to understand how medications behave in patients.

Developing assays that meet FDA and EMA validation guidelines

Running plasma samples on triple quadrupole mass spectrometers

Generating concentration-time curves for PK modeling

Long-term and freeze-thaw stability testing of clinical samples

Medical Writing

Regulatory documents and study reports

Our writers prepare the scientific documents needed for regulatory submissions, from study protocols to final clinical study reports.

Writing protocols that define objectives, endpoints, and methods

Drafting CSRs following ICH E3 structure and content guidelines

Creating investigator brochures that summarize preclinical data

Preparing Module 2 summaries for CTD-format regulatory dossiers

Project Management

Timeline and budget coordination

We keep your clinical development program on track by coordinating teams, managing budgets, and solving problems before they cause delays.

Creating Gantt charts with milestones for IND filing and database lock

Tracking burn rates and forecasting costs for CRO vendors

Running weekly team calls with sponsors, sites, and central labs

Identifying enrollment bottlenecks and implementing action plans

Regulatory Services

CDSCO, USFDA, and global submissions

We help you navigate CDSCO, USFDA, and other regulatory pathways to get your drug approved and marketed.

Preparing regulatory strategies for orphan drugs and 505(b)(2) applications

Compiling IND packages including Form FDA 1571 and CMC data

Submitting applications to institutional ethics committees

Responding to information requests from health authorities

Bio Statistical Services

Study design and statistical analysis

Our statisticians design studies, calculate sample sizes, and analyze trial data to answer whether your treatment actually works.

Writing statistical analysis plans that specify primary endpoints

Performing power calculations to determine how many subjects needed

Running SAS programs for ANCOVA models and survival analysis

Creating tables, listings, and figures for clinical study reports

Pharmacovigilance

Safety monitoring and adverse event reporting

We monitor drug safety throughout clinical trials and post-marketing, tracking adverse events and ensuring patient protection.

Setting up safety databases and reporting systems

Processing and coding adverse events using MedDRA terminology

Preparing expedited safety reports for serious adverse events

Conducting signal detection and periodic safety update reports

Clinical Data Management

EDC systems and data quality control

We design case report forms, build EDC databases, and ensure your clinical data is clean, accurate, and ready for analysis.

Building electronic data capture systems in platforms like Medidata Rave

Writing edit checks and validation rules to catch data errors

Running data cleaning queries and resolving discrepancies

Performing database locks and delivering analysis-ready datasets

Central Laboratory

Clinical lab testing and sample management

Our central lab processes clinical samples from trial sites, running standardized tests to ensure consistent, high-quality laboratory data.

Processing blood, urine, and tissue samples from clinical sites

Running hematology, chemistry, and immunology panels

Maintaining sample chain of custody and storage conditions

Delivering lab results with reference ranges and flagged abnormals

Let's Talk About Your Study

Whether you're planning a BA/BE study or a multi-center trial, we'd like to hear about your project.

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