At Clinical Conduct Associates we offer the following levels of study management:
- Project Management
- Study Support
- Study Assessment/Feasibility
- Study Preparation
- Study Conduct
- Study Close-down
- Clinical Research Resourcing
- Site support
- Central Administrative Support
- UK and Irish Ethics Submissions
- Site Training
Project Management
Clinical Conduct Associates understand the integral role project management plays in the success of a study. From ethics application, to site initiation, to recruitment and retention of patients, to financial management and finally close-down of the study, the Clinical Research Site Manager assigned to your study will provide a high quality service. We offer a single point-of-contact for the study and ensure transparent communication at all times.
At Clinical Conduct Associates our Clinical monitoring staff have a broad range of therapeutic experience with at least 3 years Clinical Research experience. The monitor’s role requires flexibility and versatility and our monitor’s are able to adapt quickly to your company’s specific requirements.
Study Support
Study Assessment Services
Fundamental to the feasibility process are our Clinical Research Site Manager’s. They will provide input into your protocol and review for consistencies with Irish procedures, ethics and impact on recruitment. We can also assist in providing solutions to make the study more workable in Ireland. Having been previously assigned to specific hospital consultants, our Clinical Research Site Manager’s have established an excellent understanding of each hospital, the consultant's department their patient database and the R&D departments. We utilize this knowledge and understanding to provide our Clients with information that enables them to make protocol and site selection decisions that are scientifically and commercially sound.
Study Start-up Services
Our Study Management team establishes and maintains a level of communication with our Sponsors to ensure all study related matters are discussed and agreed up-front. Particular attention is made to study timelines, recruitment updates and action plans. Above all, we are keen to ensure our Sponsor's key performance indicators are achieved, if not bettered. Managed centrally by Study Management, our Clinical Research Site Manager’s proactively prepare for study start-up by identifying suitable patients, obtaining regulatory and ethics approval in conjunction with site staff and liaising with relevant hospital departments. They are equipped with extensive knowledge of what really drives the clinical process forward, ensuring successful patient recruitment.
Study Conduct Services
Study Management monitors patient recruitment and progression through the study, provides regular study update reports and attends study review meetings and monitoring visits with the Sponsor to ensure the timely delivery of study objectives. Action plans are promptly produced and implemented to address issues such as protocol amendments.
Study Close-Down Services
Our Clinical Research Site Manager’s work closely with Sponsors to ensure data queries are resolved quickly and fully. We encourage our Sponsors to discuss performance and share feedback throughout the study. Finally we liaise with our Sponsors to provide investigators and patients with study results.
Site Support
Instead of relying on existing overstretched clinical staff we provide study specific support via our Clinical Research Site Manager’s, study monitors and our Research Nurses. Our Clinical Research Site Manager’s, study monitor’s and research Nurses form an integral part of the clinical research team and work in collaboration with the investigator, relevant hospital departments and our Sponsor. They actively manage all aspects of the study, including management of essential trial documents, patient recruitment and the provision of on-going study assistance to the Investigator and Sponsor.
Rapid recruitment of patients and their compliance is achieved by our Clinical Research Site Manager’s committed approach to patient identification and strong patient management skills. This strategy ensures data collection of the highest quality, and allows us to consistently achieve our recruitment and quality targets.
Central Administrative Support
Our central administrative office in Cork co-ordinates all trial activities across all sites in Ireland acting as a single-point of communication and provides a professional and proactive approach to study management.
UK and Irish Ethics Submissions
At Clinical Conduct Associates we can perform all or part of your ethics submissions for both Ireland and the UK. We have a dedicated team with considerable ethics submission experience, and who have excellent relationships with Regional Ethics Committees across Ireland and the UK. We have also established several excellent ongoing working relationships with R&D departments and Risk Managers throughout the UK and Ireland ensuring unnecessary delays are prevented.
Site Training
Clinical Conduct Associates training courses and workshop sessions are dedicated to understanding the concepts and principles that have helped mould the industry into what it is today. This gives each prospective student the opportunity to understand how the industry is progressing, so that when they take their place amongst industry professionals, they will not only be able to help continue that development, they will also be able to help shape it’s future. Understanding the value and importance of ICH GCP and it’s implementation within a clinical trial and biopharmaceutical setting is vital to the continued safety of clinical patients, which above all things is what clinical ethics holds as it’s highest benchmark. Understanding and valuing these ideals promotes more diligent monitoring practices such as source document verification, strict compliance requirements, drug accountability and ultimately the veracity of the data that is collected from the different stages of clinical trials.
At Clinical Conduct Associates we provide training in;
- Introduction to Clinical Research
- Introductory and advanced ICH GCP
- Regulatory and GCP Audit Preparation
- Study Specific and Multi Centre Site Project Management
- Presentation Skills
- Overview of the EU GCP Directive and the National Implementation guidelines
- SOP Training