Full Service CRO Solution
Our full-service CRO solution provides planning and execution of a clinical study, including oversight and accountability for key milestone delivery, from our centralised project management team.
Specialising in the design, implementation, monitoring, data management and delivery of highly complex and challenging clinical trials, our project managers work in close collaboration with our clients.
Through our many years of working in this field, our experienced team has a wide range of industry partnerships that gives us access to large patient cohorts across the globe, and our medical services team delivers effective management of single or multiple study sites and high standards of patient care.
Our team has years of experience in the delivery of clinical trials and takes pride in helping our clients get new and innovative products into the clinic allowing patients access to potentially life changing treatments. We see ourselves as an extension of the client’s team with a shared passion for improving patient care. Our project teams are assembled based on their specific expertise and fit for our clients’ requirements.
All our project managers, CRAs and CTAs work towards a common goal of efficient clinical trial delivery on time and budget whilst maintaining patient safety, data integrity and an inspection ready trial master file.
Effective data management is a critical success driver in every clinical trial. We use the latest technology to modernise the clinical trial process, increasing efficiency, enabling collaboration and improving trial performance.
All our senior data managers have over 15 years’ industry experience. We embrace the implementation of the latest technology, including patient wearables and artificial intelligence (AI), to achieve compliance objectives and delivery of high-quality patient data to support trials. Our expertise covers all aspects of data management and digital health.
We identify the critical data risks in a trial, design data capture systems and implement processes to minimise errors in the data collection process. We ensure that data validations are in place for all patient data sources and coordinate the delivery of all data to support interim and final data deliverables.
We apply standardised and established processes in the development of therapeutic area-specific electronic case record forms (eCRFs) and can manage studies efficiently in any therapeutic indication. All our selected user-friendly, cloud-based electronic data capture (EDC) systems are regulatory and 21 CFR Part 11-compliant.
Our data management services include:
Statistics and Programming
The Aptus statistics and programming group is able to draw on their many years of industry experience to provide everything from sample size justification for study designs, through statistical analysis plans, design and programming of tables, listings and figures, interim and safety review dataset analyses to the generation of the final statistical report.
Many of the statistical team have attended regulatory review meetings with competent authorities across the globe including MHRA, FDA and EMA providing justification for trial designs, patient population selection and analysis plans for clinical studies. They have successfully justified innovative approaches to trial design and analysis in order to contain cost and minimise timelines whilst maintaining the robustness and integrity of the study.
Our experienced pharmaceutical medical team offers a full clinical service to ensure the highest standards of drug safety and efficacy assessment, in a patient-centred manner, ensuring the emerging safety profile of treatments and devices is well understood.
To optimise trial success rates, our clinicians and medical scientists collaborate with our expert statisticians to gather the data for clinical decision making. With expertise in all clinical trial stages, a wide range of small and large molecules in multiple disease areas and classic and novel trial designs, we provide a comprehensive and integrated service, working on-site where needed as part of our clients’ clinical team.