Comprehensive Clinical Research Solutions Across the Development Lifecycle. At Ardent Clinical Research Services (ACRS), we offer a comprehensive suite of services that span the entire clinical development lifecycle — from early-phase trials to regulatory submissions. As a full-service Contract Research Organization (CRO) headquartered in Pune, India, with operations in Hyderabad, we are committed to supporting global pharmaceutical, biotech, and healthcare companies with tailored, high-quality clinical research solutions.
We manage end-to-end clinical trial operations across all phases:
Phase I: First-in-human studies, dose-escalation studies, and safety/tolerability evaluations in healthy volunteers or patients.
Phase II: Efficacy and dose-ranging studies in patient populations.
Phase III: Large-scale, multicenter trials for regulatory approvals.
Phase IV: Post-marketing surveillance and real-world evidence generation.
We ensure full compliance with ICH-GCP, CDSCO, US FDA, EMA, and other global regulatory bodies.
Our specialized capabilities include:
Conducting BA/BE studies for generics development and regulatory submission
Well-equipped Phase I units with in-house clinical, bioanalytical, and statistical support
Services include study design, protocol writing, volunteer recruitment, dosing, sampling, analysis, and reporting
We offer:
PK/PD study design and execution for NCEs, biologics, and biosimilars
Advanced bioanalytical services with validated LC-MS/MS methods
Detailed statistical modeling and interpretation
Our expert medical writers develop:
Clinical protocols and investigator brochures
Informed consent documents (ICDs)
Clinical study reports (CSRs), safety narratives, and CTD modules
Scientific publications, manuscripts, and regulatory documents
We provide:
Clinical data capture via EDC or paper CRFs
Data cleaning, coding (MedDRA, WHO-DD), and database lock
Advanced statistical analysis, including interim analyses and final CSR generation
Adaptive design simulations and protocol statistical consultation
We offer regulatory support across:
Clinical trial applications (CTA/IND) and ethics committee submissions
Product registration dossiers (CTD/eCTD formats)
Interactions with CDSCO, EMA, US FDA, TGA, MHRA, and more
Regulatory strategy planning and gap analysis
We support drug safety through:
Safety monitoring, signal detection, and risk assessment
AE/SAE reporting, narrative writing, and case processing
Development of DSURs, PSURs, and PBRERs
End-to-end PV system setup and audit support
We assist in:
Site identification, feasibility, and qualification
Site training, initiation, and close-out visits
On-site and remote monitoring by trained CRAs
GCP-compliant monitoring reports and query resolution
We assist in:
Assistance in preparing EC submission packages
Investigator training on GCP, protocol, and regulatory responsibilities
Recruitment support and subject retention strategies
We conduct trials across a broad range of therapeutic areas including:
Oncology
Gastroenterology
Neurology
Infectious Diseases
Cardiology
Endocrinology & Metabolism
Respiratory
Dermatology
Precision-Driven Insights for Regulatory-Grade Clinical Outcomes
Expert guidance on statistical methodologies aligned with regulatory expectations. Support for pre-IND meetings, protocol reviews, and regulatory agency interactions.
Selection of optimal design methodologies tailored to the therapeutic area and objectives. Adaptive design strategies and innovative trial designs as required.
Accurate and defensible sample size calculations using advanced statistical models. Justification based on expected treatment effects, power, and significance levels.
Generation of randomization schemes and Interactive Web Response System (IWRS) integration. Stratified or block randomization schedules to minimize bias and ensure balance.
Development of comprehensive SAPs detailing all planned analyses. SAPs fully aligned with protocol objectives and regulatory standards including USFDA, EMEA, ICH-GCP E9/E3.
Programming of datasets, analysis variables, and outputs using CDISC standards (SDTM, ADaM). Validation of all programming deliverables through robust QC processes.
Design and execution of interim analyses with pre-specified stopping rules. Support for DSMB/IDMC meetings and adaptive trial decisions.
High-quality, publication-ready TLFs for inclusion in clinical study reports and submissions. Custom visualizations for clear data interpretation and review.
Full statistical contribution to Clinical Study Reports (CSR). Integrated Summary of Safety (ISS) and Efficacy (ISE) support for regulatory dossiers. Compilation of statistical outputs for eCTD submissions.