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Clinical Research Services

Regulatory Affairs

Strategic Regulatory Solutions Engineered for Approval Success

Regulatory submission transcends documentation—it demands scientifically robust strategies that establish product value and safety credibility with regulatory authorities. Leveraging comprehensive expertise across global regulatory frameworks, BXPLANT’s Regulatory Affairs team delivers integrated strategic guidance from IND/CTA planning through marketing authorization, optimizing every stage of the approval pathway to maximize regulatory success and accelerate market access.

Regulatory Affairs (RA) Services
  • IND/CTA strategy formulation and comprehensive submission dossier preparation
  • CTD Module 2.x/3.x authoring: clinical overview, non-clinical summaries, and quality documentation
  • Global regulatory readiness: pre-approval inspections, GxP audits, and deficiency response
  • Scientific justification packages and regulatory inquiry response management
  • Full lifecycle regulatory consulting: preclinical strategy through post-approval lifecycle management

Medical Affair & Writing

Crafting Scientifically Rigorous Documents that Establish Regulatory Confidence

In clinical development, documentation transcends record-keeping—it constitutes the scientific foundation upon which regulatory agencies evaluate product safety, efficacy, and benefit-risk profiles. Strategically architected documents that articulate robust clinical rationale and compelling evidence narratives are instrumental in expediting regulatory review cycles and maximizing approval probability.

Medical Writing Services
  • Development and lifecycle management of core regulatory documents: Protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs)
  • Expert authoring of CTD Modules 2.4/2.5/2.7, regulatory deficiency responses, and scientific justification packages
  • Integrated safety and efficacy narratives synthesizing DM/STAT outputs and pharmacovigilance data
  • Document architecture optimized for ICH E3/E6/E9/E2F compliance and CDISC conformance
  • Transformation of real-world evidence and observational study findings into submission-grade deliverables
  • Scientific manuscript preparation and peer-reviewed publication support

Clinical Operations

Strategic Site-Level Execution that Transforms Protocols into Quality Data

Clinical Operations transcends site coordination—it represents sophisticated project orchestration integrating regulatory compliance, proactive risk mitigation, data integrity assurance, and patient safety stewardship. Operational excellence at the site level directly determines data quality, protocol adherence, and ultimately, study success.
Leveraging extensive pharmaceutical industry experience and proven execution capabilities, BXPLANT’s Clinical Operations team delivers solution-oriented study management from protocol finalization through database lock and regulatory submission. Our specialized expertise encompasses advanced therapy medicinal products (ATMPs), regenerative medicine trials, and extended follow-up studies, ensuring flawless execution even in high-complexity protocols requiring stringent regulatory alignment and uncompromising quality standards.

Clinical Operations Services
  • Risk-based monitoring (RBM) strategy development: comprehensive monitoring plans and risk mitigation frameworks
  • Targeted source data verification (SDV) and source data review (SDR) with adaptive on-site, remote, and hybrid monitoring approaches
  • Specialized operations for long-term follow-up (LTFU), cell & gene therapies, and complex logistics coordination
  • Independent rater/assessor management: training, inter-rater reliability optimization, and blinding integrity maintenance
  • Pre-inspection readiness and regulatory audit support ensuring GCP/ICH compliance and defense readiness
  • Quality management systems: continuous surveillance, metrics-driven oversight, and data integrity assurance
  • Protocol deviation management and corrective/preventive action (CAPA) implementation for continuous improvement
  • Real-time stakeholder communication networks across sites, investigators, CROs, and vendors for agile decision-making

Data Management & Biostatistics

Strategic Data Science Driving Regulatory Credibility through Integrity and Statistical Rigor

Data Management (DM) and Biostatistics (STAT) transcend technical execution—they constitute strategic scientific disciplines that establish data credibility, ensure reproducibility, and ultimately determine regulatory submission success. Flawless data integrity and statistically robust evidence are foundational to gaining regulatory confidence and approval.
Leveraging comprehensive expertise in global data standards and advanced statistical methodologies, BXPLANT’s DM/STAT team delivers end-to-end data excellence from protocol design through database lock, statistical analysis, and regulatory submission. We transform raw clinical data into clear, defensible, and reproducible statistical evidence that substantiates efficacy claims and maximizes the probability of clinical and regulatory success.

Data Management & Biostatistics Services
  • EDC system configuration, edit check logic programming, and comprehensive data validation protocols
  • Centralized statistical monitoring (CSM) and risk-based data surveillance for proactive quality oversight
  • Medical coding to global standards: MedDRA (adverse events) and WHODrug (concomitant medications)
  • External data integration and management: central laboratories, medical devices, ePRO platforms, imaging cores
  • Sample size determination and statistical power optimization for efficient trial design
  • Statistical Analysis Plan (SAP) development aligned with ICH E9 and regulatory guidance
  • Statistical programming and analysis using validated SAS/R platforms with reproducible code standards
  • Tables, Listings, and Figures (TLFs) generation for integrated CSR statistical sections and results interpretation
  • CDISC-compliant SDTM/ADaM dataset creation with define.xml specification and full regulatory submission validation

Pharmacovigilance & Post-Market Safety

Building Regulatory Trust Through Comprehensive Safety Lifecycle Management

Pharmacovigilance transcends adverse event reporting—it establishes the scientific foundation for regulatory confidence by systematically demonstrating favorable benefit-risk profiles throughout a product’s lifecycle. Robust safety management is integral to approval success, lifecycle maintenance, and sustained market competitiveness.

BXPLANT’s Pharmacovigilance team delivers fully integrated safety surveillance systems across pharmaceuticals, biologics, medical devices, and IVDs—spanning clinical development through post-marketing phases. Our globally compliant safety strategies align with FDA, EMA, MFDS, and PMDA requirements, ensuring regulatory confidence while supporting risk mitigation and evidence-based decision-making at every stage.

Pharmacovigilance & Safety Services
  • Clinical Development Safety
    – SAE/SUSAR medical assessment, causality evaluation, and expedited reporting to authorities
    – Safety narrative development and individual case safety report (ICSR) authoring
    – Multi-stakeholder safety communication: IRB notifications, sponsor alerts, authority correspondence
    – Data Management reconciliation and safety database quality assurance
    – Development Safety Update Reports (DSUR) and aggregate safety analysis
  • Medical Device & IVD Safety Management
    – Device adverse event evaluation and vigilance reporting (MDR, FSCA)
    – Post-Market Clinical Follow-up (PMCF) safety protocols and data integration
    – Manufacturer incident investigation and field safety corrective actions
  • Post-Market Safety Surveillance
    – Post-marketing surveillance (PMS) programs and non-interventional studies (NIS)
    – Safety-focused patient registries and long-term safety data collection
    – Real-world safety monitoring and delayed adverse event tracking
    – Benefit-risk reassessment and safety profile evolution analysis
  • Regulatory Compliance & Risk Management
    – Global pharmacovigilance compliance (FDA, EMA, MFDS, PMDA standards)
    – PSURs/PBRERs: aggregate safety reporting and periodic benefit-risk evaluations
    – Risk Management Plans (RMP): development, implementation, and effectiveness assessment
    – Safety signal detection, trend analysis, and proactive risk mitigation strategies