End-to-End Clinical Services
Accelerating molecules to market. We provide fully integrated, ICH-GCP compliant clinical solutions ranging from early stage pre-clinical design to full-scale clinical trial monitoring and statistical reporting.
BA/BE Studies
Xplora Clinical Services designs, coordinates, and executes Bioavailability and Bioequivalence (BA/BE) studies. These are essential for generic pharmaceutical product registrations globally. We partner with state-of-the-art clinical facilities that conform to DCGI, USFDA, EMA, and WHO inspections.
Our bioanalytical capabilities handle complex sample extraction and assays with high sensitivity, utilizing modern LC-MS/MS setups and validated PK software (WinNonlin) for pharmacokinetic metrics.
Core Capabilities:
* Single & Multiple Dose Studies (Fast & Fed states)
* Replicate and Semi-Replicate Study Designs for Highly Variable Drugs
* Bioanalytical Method Development and Validation
* Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling
* GLP-Compliant Data Archival and Regulatory Submission Support
Biostatistics
Data without expert interpretation is incomplete. Xplora’s biostatistics department delivers comprehensive statistical design and analysis for clinical trials across all phases. Our biostatisticians participate directly in study design and protocol formulation to ensure that the scientific objectives are matched by statistical power.
We work in strict compliance with ICH E9 guidelines, generating CDISC-compliant datasets (SDTM, ADaM) and compiling validation plans for regulatory review.
Core Capabilities:
* Sample Size Calculation and Power Analysis
* Randomization Schedules & Blind Maintenance Procedures
* Statistical Analysis Plan (SAP) Writing & Mock Table/Listing Designs
* SAS & R Programming for Inferential Statistics
* CDISC Data Conversion and Formatting (SDTM / ADaM datasets)
* Interim Analysis Planning and Data Safety Monitoring Board (DSMB) Support
Clinical Data Management
Xplora Clinical Data Management ensures clinical data is clean, secure, structured, and audit-ready. By implementing high-tier electronic data capture (EDC) systems, we reduce trial cycle times and improve overall validation efficiency.
Our CDM workflow follows 21 CFR Part 11 requirements, safeguarding patient confidentiality through advanced user permission controls and full database access logging.
Core Capabilities:
* eCRF Design, Database Build, and UAT (User Acceptance Testing)
* Data Management Plan (DMP) & Data Validation Plan (DVP) Creation
* Discrepancy Management and Automated Query Issuance
* Medical Coding (using MedDRA and WHO-DD databases)
* SAE (Serious Adverse Event) Reconciliation and Database Lock Protocols
* Comprehensive Audit Trail Exports
Medical Writing
Regulatory success depends on clear, transparent scientific documentation. Xplora’s medical writing team possesses the expertise to convert complex clinical findings into cohesive, peer-reviewed, and regulatory-approved documents.
We work in collaboration with principal investigators, medical monitors, and biostatisticians to draft protocols and clinical study reports (CSRs) matching international standards.
Core Capabilities:
* Clinical Trial Protocols & Amendment Writing
* Investigator Brochures (IB) & Patient Information Leaflets (PIL)
* Informed Consent Forms (ICF) compliant with regional ethics codes
* Clinical Study Reports (CSR) matching ICH E3 guidelines
* Manuscript Preparation for High-Impact Medical Journals
* Abstracts and Poster Presentations for Global Conferences
Pre Clinical Development
Before testing a compound in humans, safety and biological activity must be established. Xplora offers preclinical study design and management to help sponsors transition their compounds from laboratory benches to IND/CTA filings. We specialize in coordinating toxicological and pharmacological assays.
Our preclinical partners operate under Good Laboratory Practices (GLP) standards, ensuring that data is valid for global regulatory submissions.
Core Capabilities:
* In Vitro and In Vivo Pharmacological Screening
* Acute, Sub-Acute, and Chronic Toxicology Studies
* Pharmacokinetic (PK) and Absorption, Distribution, Metabolism, Excretion (ADME) Profiles
* Safety Pharmacology Screenings
* Dose Range Finding (DRF) and First-in-Human (FIH) Dose Calculations
Site Management Services (SMO)
Xplora operates as a premium Site Management Organization (SMO), connecting clinical trial sponsors with high-performing research sites across India. We place dedicated Clinical Research Coordinators (CRCs) at investigator sites to manage daily trial logistics, patient recruitment, and source data documentation.
Our localized focus allows us to navigate institutional ethics committees (IEC) rapidly, facilitating timely trial startups and high patient retention rates.
Core Capabilities:
* Site Feasibility Assessments & Investigator Site Selection
* Ethics Committee Submission, Coordination, and Approval Management
* Dedicated On-Site Clinical Research Coordinators (CRCs)
* Patient Identification, Recruitment, and Compliance Monitoring
* Source Document Creation and Trial Master File (TMF) Maintenance
* Investigational Product (IP) Storage, Inventory, and Accountability Log Management
Partner with India’s Premier CRO
Accelerate your regulatory pipeline and bring therapeutic solutions to life with absolute compliance, quality execution, and reliable site delivery.