Functional
Support

At the heart of any successful project is effective project management. We pride ourselves on our holistic approach, by placing the patient at the heart of our thinking and by understanding the needs and pressures placed on our study partners, we ensure that our projects will deliver for all stakeholders.  Your project will be led by an experienced Project Manager who acts as your primary contact, ensuring optimum transparency and excellent communication throughout the study lifecycle. Additionally, O4 managed projects benefit from executive director oversight, so you can be assured that your study is being performed within timelines and to the very highest standards.

Our clinical operations team consist of highly motivated, multi-disciplinary experts, who work closely to meticulously execute every aspect of study activity, whilst proactively assessing and identifying risks. Our teams operate in adherence with our robust quality management system and industry best practices. By building strong relationships with your team and utilising our proprietary methodologies, we create the optimal environment to deliver successful studies, on time and within budget.

We understand that study sites are busy with many competing demands on their time. Simply expecting our sites to deliver is not enough. We have to take proactive steps to support them if we expect to achieve the recruitment and retention we require. At O4, we offer you the opportunity to benefit from a customised site management programme for your studies, from the simplest through to the most complex, enabling your study teams to have a clear focus on reducing study duration through exceptional site performance, compliance and communication. Our holistic, custom designed approach, increases awareness and engagement amongst study teams and their patients. This collaborative and innovative approach builds trust and ensures that sites meet or exceed your targets.

At O4, we place great emphasis on the feasibility stage, recognising the critical need for a robust and rigorous foundation for every study. Put simply, if we don’t invest sufficiently and optimise this formative stage, we shouldn’t be surprised if issues arise downstream and projects become significantly more challenging to deliver.

Over time, our clinical operations team have developed strong relationships with a large network of Key Opinion Leaders, Investigators and investigative sites across Hospital, General Practice and Community Pharmacy. This enables you the opportunity to access a breadth of therapeutic experts who work in conjunction with our Medical Advisory Group and clinical operations team to comprehensively evaluate and optimise your studies from the outset.  Coupling this with our robust site level feasibility process means that your sites can achieve rapid start-up, accelerated patient recruitment, high patient retention, good data quality and exceptional service on every level.

It is widely recognised that the large majority of studies fall behind schedule, often as a consequence of poor patient recruitment and retention rates.

As part of our customised site management programme, we at O4 support your study teams by developing and agreeing comprehensive site specific support plans. This collaborative process ensures that each site team understand the issues, are invested in our shared goal and are open to ongoing engagement and proactive intervention if, and when it is required. Once in place, regular communication and monitoring of performance ensures effective delivery of your studies so that you can minimise costly delays and ultimately achieve your study targets.

At O4, our medical writing service can support you with all aspects of the study cycle, from protocol development through to clinical study report generation. This includes working with patient advocacy groups to develop informative but user friendly Patient Information Leaflets/ Informed Consent Forms and producing highly effective abstracts, posters and manuscripts developed as part of a co-ordinated publication strategy. We are accustomed to working within tight timelines to adhere to sponsor review processes and co-ordinating input from various stakeholders including steering committees and medical reviewers. We ensure that every piece of medical writing we complete on your behalf is designed and reported to the highest standard by combining our academic, industry and therapeutic expertise, and utilising our medical advisory board and patient advocacy group resources as required.

We can offer you access to our bespoke in-house processes developed to track and optimise the efficient and effective delivery of large volumes of Competent Authority submissions in addition to Research Ethics submissions. At O4, we have a dedicated team with expansive regulatory experience, offering a range of regulatory services to fast-track submissions on your behalf.

During clinical monitoring we ensure that patient safety is our top priority and that data integrity is robust. Our experienced Clinical Research Associates have an in-depth knowledge of national and international regulations, practices and cultures. We appreciate that a successful Clinical Research Associate site relationship is based on trust, mutual respect, shared goals and objectives. Our team invest time to establish and strengthen these relationships, building long-term connections, which benefit both your active and future studies.

We at O4 recognise that every product is unique and our first priority is to understand your objectives.  By partnering with pharma, biotech and consumer health organisations, O4 Research has a strong track record of developing research concepts and delivering successful projects across many disciplines. We have developed a shared vision with an extensive network of clinicians, allied healthcare professionals, patient advocacy and focus groups. This is fundamental in creating a custom-designed ‘road map’ which integrates development needs, budgetary requirements and study complexities for your study. We also ensure you are able to maintain control and oversight by keeping you informed at all times of the progress of your study.

The clinical research and product development process can be a complex and intricate pathway to navigate. With decades of experience and knowledge gained in the world’s leading pharmaceutical, biotechnology, CRO and public health care sectors, our team has gained the skills and expertise needed to guide you and your team through all stages of clinical development.

Our experienced team has the capability to manage all of your data needs, every step of the way. We can offer you a therapeutic area knowledge-driven, end-user focused approach to clinical trial data management and statistics developed in close conjunction with our trusted technical partners. We design intuitive CRF/eCRF and EDC systems which enable an efficient data entry process and facilitate user friendly query resolution, data reconciliation and transfer. As a direct consequence, your projects will benefit from the collation of high quality data which maximises downstream statistical analysis outputs.