Independent Freelance Clinical Research Professionals Network Focused on Biotechs & Emerging Pharma, Supporting CROs and Sponsors as Needed.
Flexible. Experienced. Inspection-Ready.
ABOUT US
We are a network of independent, highly experienced Freelance Clinical Research Professionals providing site monitoring, study support, and risk-based oversight for global trials.
Our team brings a combined 46+ years of clinical monitoring experience, with deep exposure to Oncology, Rare Diseases, Immune-modulators, Dermatology, Psychiatry, Endocrine/Metabolic, Vaccines, Gastroenterology, and Nephrology.
Our Team Structure:
🇦🇺 Australia Clinical Operations Team – Combined Expertise
Our Australia team brings 25+ years of combined Senior CRA,CTM and study start up experience, delivering strong leadership across early-phase, oncology, and complex global clinical programs.
Key Strengths
- Extensive Phase I–III Expertise including early-phase oncology and complex multi-centre studies
- Leadership across multiple global Phase I oncology protocols
- Advanced Clinical & Technical Skills: Dose-escalation studies, RECIST, CTCAE assessments
- Proven high-quality TMF/ISF oversight with audit-ready documentation
- Each Senior CRA manages 10+ active sites concurrently in global studies
- Experienced in rescue site management and restoring performance
- Inspection & Compliance Excellence: Preparing for FDA, TGA, sponsor, and internal audits
- Strong leadership in feasibility, site selection, oncology-focused training, and communication
- Flexible Resourcing Models: Full FTE, part-time, or per-visit support
🇮🇳 India Clinical Operations Team – Combined Expertise
Our India team brings 20+ years of combined Senior CRA and Clinical Operations experience, supporting global and local studies across diverse therapeutic areas.
Key Strengths
- Strong Phase I–III & Multi-Therapeutic Expertise including oncology, metabolic disorders, infectious diseases
- Deep regulatory and start-up expertise within India's framework
- Experience with SUGAM regulatory portal, EC/IEC processes, timelines, and compliance
- Each CRA manages 10+ active sites concurrently, especially academic hospitals and private oncology networks
- Thorough knowledge of ICH-GCP, NDCT Rules, and sponsor SOPs
- Expert in site preparation for DCGI and sponsor audits with a focus on quality improvement
- Strong TMF/ISF management and operational excellence
- Excellent stakeholder collaboration and site engagement with top Indian research centres
- Flexible resourcing with full FTE, part-time, or per-visit models suited for growing Indian clinical research market
SERVICES
Contract CRA & Clinical Monitoring Support (Australia & India)
We provide contract-based clinical monitoring, site oversight, regulatory coordination, and documentation support for Phase I–IV studies, Post-Marketing Surveillance (PMS), and Real-World Evidence (RWE) projects. Engagement options include per-visit, part-time FTE, full FTE, short-term, long-term, and rapid-coverage support.
🇦🇺 AUSTRALIA – Clinical Monitoring, PMS & RWE Support
Comprehensive Monitoring & Site Oversight
- On-site and remote monitoring for Phase I–IV, PMS, and RWE studies
- SDV, SDR, data review, and query resolution
- AE/SAE follow-up and patient safety oversight
- Protocol deviation evaluation and corrective follow-up
- ICF review, compliance checks, and site guidance
Quality Assurance Framework
- Peer review of monitoring reports
- Consistent template usage for follow-up letters and pre-visit preparation
- Internal QC checks on ISF/TMF and critical documents
Start-Up & Site Activation Support
- Feasibility and pre-study qualification
- Ethics submission coordination
- ISF/TMF setup, QC, and ongoing oversight
- IRT/CTMS setup and activation checks
Full Site Management
- Recruitment and retention support
- IP handling, accountability, and reconciliation
- Lab kit management and sample logistics
- Visit scheduling, follow-up, and compliance tracking
Audit & Inspection Readiness (TGA, FDA, Sponsor)
- ISF/TMF clean-up and documentation review
- Pre-audit QC checks and readiness assessments
- CAPA development and follow-through
- Mock audit preparation and site coaching
Rescue Monitoring & High-Risk Site Support
- Rapid deployment for delayed or high-risk sites
- Root-cause analysis for data or compliance issues
- Corrective action plans and focused monitoring
- Support for stabilising sites under tight timelines
🇮🇳 INDIA – Clinical Monitoring, DCGI Coordination, PMS & RWE Support
Comprehensive Monitoring & Site Oversight
- Monitoring for Phase I–IV, PMS, and RWE studies
- SDV, SDR, query management, and data verification
- AE/SAE safety oversight
- Protocol deviation review and resolution tracking
- ICF version control and consent quality checks
India-Specific Start-Up & Regulatory Coordination
- DCGI/CDSCO submissions through the SUGAM portal
- Ethics Committee (EC/IEC) submissions and amendments
- ISF/TMF setup, QC, and maintenance
- IRT/CTMS support during start-up and activation
Full Site Management
- Recruitment progress and enrolment tracking
- IP accountability and drug supply oversight
- Lab kit coordination and sample shipment logistics
- Visit scheduling, reminders, and action-item follow-up
Audit & Inspection Readiness (DCGI, Sponsor)
- TMF/ISF organisation and clean-up
- Compliance checks and pre-audit QC
- CAPA preparation and implementation
- Mock audit sessions and site training
Rescue Monitoring & Site Recovery
- Fast deployment for at-risk or delayed sites
- Root-cause analysis for data or operational issues
- Structured corrective action plans
- High-frequency monitoring to restore performance
Flexible Engagement Models – Australia & India
- Per-visit monitoring
- Part-time or full FTE
- Short-term or long-term assignments
- 48–72 hour rapid coverage (where available)
- Suitable for Phase I–IV, PMS, RWE, rescue, and time-critical studies
WHY CHOOSE OUR FREELANCE CRA NETWORK
CRO-Level Quality at a Fraction of the Cost
Designed for small and emerging biotechs that need reliable clinical monitoring for ongoing studies without the cost of a large CRO or unnecessary full-time hiring. Suitable for early-phase programs, oncology trials, and real-world evidence activities.
Experienced CRAs with Strong Technical Capability
Our network consists of monitors who are well-versed in clinical operations across various study designs, including first-in-human, oncology, complex Phase II/III, and Phase IV or post-marketing commitments. Their background supports efficient oversight and confident decision-making.
Multi-Region Coverage (Australia and India)
Our freelance CRA teams in Australia and India work in a coordinated model, offering streamlined operations for hybrid and multi-country trials. This structure supports continuous oversight for studies across both regions, including RWE and post-marketing surveillance environments.
Minimal Oversight Required
Each independent clinical research associate works autonomously, communicates consistently, and maintains complete inspection-ready documentation. This reduces management burden on sponsors and keeps study activity moving smoothly.
Experience with All Major Platforms
Proficient across key clinical systems including Medidata Rave, Oracle Clinical, Inform EDC, Clinion, CodeAngelo, CTMS environments, and IRT/IWRS platforms—ideal for remote monitoring, data-heavy studies, or ongoing oversight requiring strong system fluency.
Contact
Providing flexible, expert monitoring support across Australia and India, with experienced CRAs supporting trials from early development to post-marketing and real-world evidence studies.
Email Us
services@phaseclinicalresearch.com