CRO-Solutions® is proud to offer its clients a single solution for their clinical trial programmes.
A single contract with CRO-Solutions® bridges the gap for clients looking for the leading providers of clinical trial services in a diverse and complex field. CRO-Solutions® provides a bespoke offering of their own highly accomplished and experienced staff and prominent, respected companies to deliver a solution tailored to the individual resource requirements of the client.
CRO-Solutions® Data Management form collaborative and effective trial teams, across trial functions, medical experts and Sponsors. Our dedicated Lead Data Managers provide an expert point of contact for Data Management related discussion, strategising, guiding and delivering the design, build, conduct and successful lock of your trials. All completed in a secure, dependable and regulatory compliant manner.
CRO-Solutions® Data Management provide the following services:
Harnessing the quality infrastructure synonymous with the CRO-Solutions® brand, we deliver all Data Management requirements to the highest quality standards.
With the requirement for all clinical trial Sponsors to appoint a medical monitor, CRO-Solutions® has positioned itself to ensure these regulatory obligations are met with the provision of proficient and practiced medical experts to oversee the entire clinical trial activity.
The expert medics act as a point of reference for both the investigative site and wider study team members and can include the following services:
Our erudite staff have experience in an array of therapeutic areas enabling them to produce clear, succinct and compliant trial documentation.
We have the ability to produce and develop detailed and comprehensive:
Working in tandem with our on-site medical experts, CRO-Solutions® medical
writers work to ensure our clients’ required timeframes and study needs are consistently met.
CRO-Solutions® monitors work in close collaboration with our clients, to provide on and off-site monitoring services to ensure a first-class review of clinical trial data in accordance with client, or CRO-Solutions® SOPs. Whilst maintaining their independence from the MEU team, our monitors are fully familiar with the MEU systems and processes, enabling them to offer an efficient and thorough review of data.
Our monitors, provide blinded and unblinded monitoring services to sites worldwide. Irrespective of the site location, they follow a systematic, risk-based approach to deliver exceptional quality data.
CRO-Solutions® is perfectly positioned to offer pharmacovigilance services which provide a robust compliance programme for safety monitoring whilst maintaining the flexibility required for the changing nature of development programmes. From the FiH Phase I study, through to complex multi-centre and global Phase III studies, CRO-Solutions can provide support, customised for your requirements and will be your strategic partner.
CRO-Solutions® Pharmacovigilence provide the following services:
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus With a successful proven track record of managing sites across Europe, our knowledgeable and highly experienced
CRO-Solutions® project managers have strong interpersonal skills enabling coordination of all clinical trial activities and effective liaison with stakeholders. With diverse therapeutic experience, they are conversant with the complexities of trial management and mitigation and resolution of a range of issues. We pride ourselves on maintaining the same project managers from start to end of clinical trials, providing a consistent point of contact for our clients.leo.
Our proficient clinical pharmacologists have extensive experience in all aspects of protocol design, clinical
pharmacology, safety, pharmacovigilance, and patient recruitment strategies, enhancing the success of our client’s clinical trial outcomes.
With CRO-Solutions® headquarters based on a “centre of clinical excellence” hospital site, we have access to specialist clinicians and Key Opinion Leaders across the region. These experts understand the scientific complexity and study endpoints in relation to recruitment and protocol development. They translate their pharmacological understanding of the Investigational Medicinal Product into a practical, effective protocol incorporating the appropriate patient population.
At CRO-Solutions® , we recognise that the statistical integrity of your study is crucial to achieving your clinical objectives. Our Biostatistics team, comprising of both Statistics and Statistical Programming, provides expert support from study design to final submission, ensuring compliance with regulatory standards and delivering high-quality, reliable results.
Our Statistics team advises on study design, sample size calculations, and statistical methodologies to minimise bias and optimise trial outcomes. We support clients with:
Our Statistical Programming team transforms the SAP into reality, delivering high-quality, CDISC-compliant datasets and outputs to support regulatory submissions. We specialise in:
With a commitment to quality and regulatory excellence, the CRO-Solutions® Biostatistics team ensures that your clinical trial data is rigorously prepared, analysed, and reported for successful regulatory submissions.
Maintaining essential trial documentation in compliance with regulatory requirements demands significant time, attention to detail, and resources. At CRO-Solutions®, we provide expert support in Trial Master File (TMF) setup, management, and ongoing maintenance, ensuring seamless organization and inspection readiness at all times.
As a central hub for all trial stakeholders, our team collaborates closely with each relevant party to gather, maintain, and systematically file all required documents. Our CRO-Solutions® Project Managers work across study teams to safeguard the integrity and compliance of our clients’ TMFs, aligning with their specific needs, CRO-Solutions® SOPs, and evolving regulatory requirements.
With our meticulous approach and industry expertise, we ensure that your trial documentation remains accurate, audit-ready, and fully compliant—allowing you to focus on the successful execution of your clinical trials.
