Explore our specialized expertise in high-quality clinical research solutions tailored to your needs. Our dedicated team is here to support you navigate the complexities of healthcare projects with ease, ensuring accelerated study timelines, cost efficiency, and quality driven results.
CRO-Solutions® provides full-service clinical project management and regulatory support tailored to your study needs. With experienced project leaders and regulatory experts, we ensure timely, compliant trial delivery—from initiation to close-out—backed by strong communication and operational control across all stakeholders.
CRO-Solutions® delivers Clinical Project Management and Regulatory Services designed to ensure your clinical trial is executed efficiently, compliantly, and with consistent leadership throughout. Whether as part of a full-service model or a standalone offering, our services include:
Project Management Expertise:
Full oversight from trial initiation to close-out.
Timeline, budget, and risk control tailored to project complexity.
Coordination of multidisciplinary teams, sites, and vendors.
Dedicated project managers offering continuous leadership and communication.
Regulatory Affairs Support:
Strategic input for early-phase regulatory planning.
CTA submissions and preparation of supporting documentation.
Ethics committee submissions and interaction with regulatory bodies.
Ongoing oversight to ensure regulatory compliance throughout trial execution.
Operational Integration:
Seamless collaboration with internal functions and external partners.
Monitoring oversight and quality assurance processes.
Trial Master File (TMF) setup, maintenance, and audit readiness.
Global Capability:
Experience managing studies across diverse geographies.
Flexible resourcing and regional regulatory expertise.
CRO-Solutions® offers expert clinical pharmacology support that spans protocol design, safety planning, pharmacovigilance, and patient recruitment. Based within a leading hospital site, the team works alongside specialist clinicians and Key Opinion Leaders to develop scientifically sound, recruitment-optimized protocols. This translational approach ensures the successful alignment of the IMP with an appropriate patient population, enhancing trial outcomes and operational success.
CRO-Solutions® provides expert clinical monitoring services that blend regulatory compliance with operational efficiency. With both blinded and unblinded monitoring options and detailed site feasibility evaluations, our team ensures robust trial oversight and strong site performance from initiation through close-out.
Standalone Monitoring & Consultancy Services
In addition to our integrated services, CRO-Solutions® provides flexible standalone monitoring and clinical trial consultancy options. Whether you require independent monitoring, additional resource support, or expert guidance on trial design and operational strategy, our team delivers tailored solutions to meet your specific needs.
These services are ideal for clients who require short-term expertise, oversight of specific trial components, or strategic input without engaging a full-service solution. Backed by deep industry experience, our consultants and monitors offer practical, actionable support focused on quality, compliance, and efficiency.
CRO-Solutions® offers high-quality, tailored clinical monitoring services designed to ensure data accuracy, regulatory compliance, and operational excellence across all trial phases. Key services include:
On-site and Remote Monitoring:
Blinded and Unblinded Monitoring:
Independence with System Familiarity:
Monitors maintain impartial oversight while leveraging knowledge of site tools and workflows for efficient monitoring.
Site Feasibility Assessments:
CRO-Solutions® delivers high-quality Data Management through expert-led teams and efficient processes. From eCRF design to trial database lock, our services ensure accurate, compliant, and timely data delivery that supports seamless integration with other clinical functions.
CRO-Solutions® offers robust, compliant pharmacovigilance services that adapt to the complexities of modern clinical development. From early-phase trials to large global studies, their expert team ensures comprehensive safety monitoring and strategic oversight to support regulatory success.
CRO-Solutions® provides experienced medical monitors to help Sponsors meet regulatory obligations and ensure clinical trial safety oversight. Acting as key medical liaisons, these experts support both investigative sites and study teams. Services include reviewing critical trial documents (protocols, safety plans), resolving participant eligibility issues, and overseeing AE/SAE assessments and narrative sign-offs, ensuring trials are conducted safely and in compliance with regulations.
CRO-Solutions® Biostatistics provides comprehensive statistical and programming expertise throughout the clinical trial lifecycle. From robust study planning and regulatory-aligned documentation to CDISC-standardised outputs, the team ensures statistical integrity and submission readiness.
Sample Size & Methodologies: Calculations and techniques tailored to optimise power and reduce bias.
Randomisation Generation: Creation of schedules/lists to maintain blinding and trial validity.
SAP Development: Comprehensive Statistical Analysis Plans guiding trial data evaluation.
TFL Shell Creation: Aligned with sponsor/internal standards for accurate data presentation.
Regulatory & DSMB Support: Including interim analysis preparation and ongoing statistical oversight.
CDISC Dataset Programming: SDTM and ADaM datasets structured for submission-readiness.
Regulatory Documentation: Define.xml, annotated CRFs, and reviewer’s guides to meet agency expectations.
TFL Programming: Critical output generation for clinical study reports.
Audit Services: Independent quality checks of in-house or third-party programming work.
Collaborative Workflow: Input into SAP and TFL shell development; alignment with Data Management to ensure CDISC compliance from the outset.
CRO-Solutions® offers expert medical writing services backed by experienced professionals across diverse therapeutic areas. The team delivers clear, compliant, and well-structured documents including protocols, safety reports, white papers, and clinical study reports tailored to each trial’s requirements. Working closely with in-house medical experts, CRO-Solutions® ensures timely, high-quality documentation that supports successful trial execution and regulatory submissions.
CRO-Solutions® ensures regulatory-ready TMFs through meticulous setup, management, and maintenance processes. With oversight from experienced project managers, our TMF services support smooth audits, inspections, and documentation flow across clinical trials.
Reach out to discuss your project needs with us.
