AstraClinical Research is a full-service international Contract Research Organization (CRO) delivering Phase I–IV clinical trials, pharmacovigilance, regulatory affairs, and biostatistics with proven scientific excellence and cost efficiency.
From early-phase protocol design to post-marketing safety, we cover all scientific and operational aspects of clinical research.
Full-service management of early and late-phase trials. Rapid site feasibility, patient recruitment campaigns, investigator management, and remote & risk-based monitoring (RBM) aligned with ICH-GCP.
End-to-end drug safety services for clinical trials and post-marketing. 24/7 medical triage, ICSR processing, aggregate reporting (PSUR/PBRER/DSUR), signal detection, and Qualified Person (QPPV) coverage.
Comprehensive regulatory authoring and submission management. Navigating IND, NDA, BLA, MAA, and clinical trial authorizations (CTA/CTIS) with health authorities in North America, Europe, and Asia.
Authored by PhD and MD medical writers with specialized disease expertise. Clear, scientifically robust, and audit-ready documentation compliant with ICH E3, E6, and ICMJE guidelines.
Statistical programming in SAS and R. Production of CDISC SDTM and ADaM dataset packages, electronic data capture (EDC) setup, MedDRA/WHO-DD medical coding, and validated statistical analysis plans (SAP).
Dedicated clinical evaluations for Class I, II, and III medical devices under EU MDR 2017/745 and ISO 14155, along with longitudinal patient registries and Post-Authorization Safety Studies (PASS).
With over 500,000 enrolled subjects across 8,500 investigator hospital networks, our trial teams prioritize ethical retention, diverse cohort enrollment, and seamless patient experience.
From First-in-Human dose escalation to multinational pivotal registrational trials, AstraClinical combines regulatory agility with investigator site reach.
Early-stage drug development demands flawless volunteer safety monitoring, precise pharmacokinetic sampling, and rapid bioanalytical quantification. Our dedicated Phase I medical directors design adaptive dose-escalation protocols (3+3, Bayesian CRM) that deliver actionable PK/PD data safely and rapidly.
Phase II studies are the crucible of biopharma development. We deploy targeted patient recruitment algorithms, specialized site networks in Oncology, CNS, and Rare Diseases, and interim adaptive analysis models to confirm clinical signals while protecting sponsor capital.
Large-scale confirmatory trials require robust global logistics, harmonized multi-country regulatory clearances, and vigilant risk-based monitoring. AstraClinical coordinates multicenter trials across 28+ countries with high recruitment volume and pristine audit records.
Demonstrating real-world effectiveness, expanding market access, and fulfilling post-authorization commitments (PASS/PAES) require deep epidemiological insight. AstraClinical leverages electronic health record (EHR) registries, patient-reported outcomes, and long-term pharmacovigilance.
How AstraClinical helped biopharmaceutical and medical device sponsors overcome recruitment bottlenecks, regulatory hurdles, and compressed timelines.
A US biotech faced severe enrollment stagnation in North America due to competing trials. AstraClinical activated 42 additional vetted hospital sites across Eastern Europe and India within 9 weeks, completing full enrollment 3 months ahead of corporate milestones.
Sponsor needed synchronized submissions across FDA, EMA, and Health Canada for an ultra-rare pediatric formulation. Our regulatory team drafted complete eCTD Modules 1-5, secured orphan drug designation (ODD), and obtained ethical approvals with zero clinical holds.
Mid-sized commercial pharma needed to outsource post-marketing safety oversight for 14 licensed oncology therapeutics. AstraClinical deployed a 24/7 multi-lingual intake and automated signal detection pipeline processing 45,000 cases annually without a single late filing.
Coordinated global trials with seamless local execution across the Americas, Europe, and Asia.
Clinical study oversight, medical writing, international biostatistics center, and North American sponsor relations.
Pre-IND submissions, FDA agency liaison, and US academic oncology & rare disease clinical site networks.
Rapid clinical trial execution, centralized pharmacovigilance safety triage, and CDISC statistical programming.
Access to major hospital institutions across Colombia, Mexico, Argentina, and Brazil with high patient retention.
Experienced medical directors and specialized investigative sites dedicated to your indication.
Solid tumors, CAR-T, immuno-oncology, and biomarker-driven clinical protocols.
Alzheimer's, Parkinson's, ALS, Epilepsy, and Neuro-psychiatric trials.
Rheumatoid arthritis, Lupus, IBD (Crohn's/Colitis), and Psoriasis studies.
Pediatric and adult orphan designations with specialized decentralized logistics.
Surgical implants, regenerative orthobiologics, and musculoskeletal devices.
Rapid surge enrollment, respiratory vaccines, and antimicrobial therapeutics.
Whether you are an emerging biotechnology firm conducting a critical First-in-Human trial, or a global pharmaceutical enterprise requiring turnkey pharmacovigilance across 20 markets, our agile structure adapts directly to your operating rhythm.
Knowledgeable project teams, flexible approaches, and dedicated C-suite attention.
Niche post-marketing services, multi-country site networks, and inspection readiness.
EU MDR and FDA 510(k)/PMA clinical investigations with full ISO 14155 adherence.
AstraClinical delivered our Phase II oncology trial 4 months ahead of schedule with 99.4% data completeness. Their responsiveness and regulatory insights made all the difference.
Fully audited and compliant with worldwide healthcare agency mandates.
Select your trial phase and therapeutic focus to generate preliminary site startup intervals, site network projections, and database lock targets.
Expert analyses on decentralized trials, global regulatory harmonization, AI in pharmacovigilance, and advanced biostatistics.
How combining centralized academic hospital monitoring with localized home nursing and mobile health technologies increased patient retention by 34% in complex Phase II/III solid tumor protocols.
A critical analysis of the finalized ICH E6(R3) guidelines and practical guidance on implementing governance frameworks that satisfy both US FDA and European EMA inspectors.
How AstraClinical implemented automated natural language processing (NLP) to reduce ICSR intake triage latency by 62% while maintaining a 99.8% regulatory on-time filing benchmark.
Examining Bayesian adaptive algorithms and group sequential designs that permit sample size recalculation and early futility stopping without inflating Type I error rates.
Essential answers on study start-up speed, investigator site oversight, electronic systems, and rescue trial management.
Connect with our Medical Directors and Biostatistical leads for a preliminary feasibility review.
Our Medical Review Team will contact you under NDA within 24 hours.