Clinical Services | AstraClinical Research

SERVICE 01

Clinical Operations & Site Management (Phase I–IV)

We provide end-to-end trial management backed by over 8,500 investigator hospital sites across 28 countries. We combine risk-based monitoring (RBM) and decentralized clinical trial (DCT) methodologies to ensure exceptional patient retention and flawless protocol adherence.

• Site Feasibility & Startup: Rapid IRB/EC submission packages with median 18-day clearance • Patient Recruitment Acceleration: Multilingual patient engagement and decentralized home healthcare • Risk-Based Remote Monitoring: Continuous data surveillance aligned with ICH E6(R2)

CORE DELIVERABLES

Clinical Operations Package

Investigator contract & budget negotiation
Investigational Product (IP) cold-chain distribution
Trial Master File (eTMF) inspection readiness
Clinical Study Report (CSR) authoring under ICH E3

24/7/365 SURVEILLANCE

Drug Safety & Vigilance

Individual Case Safety Reports (ICSR) intake & triage
E2B(R3) expedited regulatory submissions
Periodic Benefit-Risk Evaluation Reports (PBRER)
Local & EU QPPV 24/7 coverage

SERVICE 02

Pharmacovigilance & Drug Safety Oversight

Maintain complete patient safety and vigilance compliance across pre-marketing clinical trials and commercial product lifecycles. Our 24/7 medical review officers and hosted safety database infrastructure guarantee zero late-submission penalties.

• Medical Triage: Board-certified physicians handling serious adverse events (SAEs) • Signal Detection: Quantitative disproportionality scoring and literature screening • Risk Management Plans: RMP and REMS authoring for US FDA, EMA, and global agencies

SERVICE 03

Regulatory Affairs & Global Submissions

From initial scientific advice meetings to formal market authorization filings, our regulatory strategists guide complex therapeutics through US FDA, EMA, Health Canada, and Asian agency pathways.

• Investigational Submissions: IND, CTA, IMPD, and Pre-IND briefing document preparation • Marketing Authorizations: NDA, BLA, MAA, and 510(k)/PMA electronic eCTD compilation • Authorized Representation: US Agent and in-country regulatory sponsorship

GLOBAL REGULATORY SHIELD

Regulatory Dossier Services

Pre-IND & scientific advice briefing dossiers
eCTD Module 1–5 compilation and validation
Health Authority inspection audit defense
Labeling & package insert localization

CDISC PLATINUM

Data & Statistical Solutions

21 CFR Part 11 compliant Electronic Data Capture
CDISC SDTM, ADaM & Define.xml 2.1 datasets
Statistical Analysis Plan (SAP) & sample size models
Independent SAS® & R double-programming

SERVICE 04

Biostatistics & Clinical Data Management

Extract conclusive clinical proof with statistical precision. From sample size simulations to CDISC SDTM/ADaM package generation, our data management ensures clean, rapid database locks under 15 business days.

• Flawless Data Cleanliness: Automated edit checks, query management, and medical coding • Interim Analyses: Blinded DSMB and IDMC statistical analysis and reporting • Regulatory Package: Ready for US FDA and EMA electronic submission validation

SERVICE 05

Medical Writing & Scientific Communication

Authored by PhD and MD medical communicators with deep therapeutic specialization. We craft clear, scientifically robust, and audit-ready documentation in full compliance with ICH E3 and E6 guidelines.

• Clinical Study Protocols & Amendments: Scientifically sound, operationally feasible designs • Clinical Study Reports (CSR): Rigorous CSRs structured to withstand health authority scrutiny • Medical Device CERs: MEDDEV 2.7/1 Rev 4 and EU MDR compliant Clinical Evaluation Reports

ICH E3 COMPLIANT

Medical Writing Portfolio

Investigator's Brochures (IB) & Informed Consents
Clinical Study Reports (Phase I–IV CSRs)
Clinical Evaluation Reports (CER) for Devices
Peer-reviewed journal manuscripts & abstracts

Comprehensive Clinical Development Services