Clinical Research Ireland’s consultancy services allow Sponsors, Investigators and Research Professionals access to a talented team of research professionals and support staff that will simplify the research process and deliver client projects on time while maintaining the highest quality standards. Our service offerings help our collaborators achieve their goals by providing a range of tailored services from the initial stages of study design and funding applications through to the research endpoints. Integral to successful grant tenders is the submission of robust project designs that are appreciative of the logistical intricacies of research project realisation. Clinical Research Ireland’s team are experts in the area of project realisation which makes them the perfect partner to support your project design and roll-out.
Clinical Research Ireland’s consultancy services include:
Site Selection and Management
Clinical Research Ireland has sites representing all of the major specialties spanning Primary Care through to Specialist Hospital Clinics. Initiation of one of our clinical sites begins with a site selection and qualification visit. All of our sites are experienced in pharmaceutical and diagnostic research and have on-site support and facilities designated for clinical research. Most importantly, our sites have large patient populations readily accessible to get quality samples in a timely fashion.
Protocol Development and CRF Design
Clinical Research Ireland helps clients achieve the optimal protocol design, establishing appropriate study objectives and endpoints, while ensuring research goals are delivered within study timelines and assigned budgets. Our protocols are brief and specific to your research needs and reflect our understanding of the realities of clinical practice. Case Report Forms (CRFs) are integral to clinical research and no matter what CRF is utilised, the quality and integrity of the captured data is of primary importance. Clinical Research Ireland can assist in the design, development and quality assurance of the CRF such that the data collected will meet the highest standards.
Clinical Research Ireland can assist with physician recruitment, management of multi-year, multi-centre research studies, data collection and site management. We customise our service offerings to meet client needs, from the pre-initiation activities to study closeout. The Project Manager has a leading role in planning, coordinating and designing a clinical project management plan to ensure successful project delivery. Continuous communication is maintained with all appropriate stakeholders to ensure relevant parties are kept fully briefed on study progress and any significant study or site issues are rapidly and appropriately resolved. Project tracking allows us to monitor studies to ensure that project goals and objectives are met within required timeframes and budgets.
Clinical Research Ireland's Clinical Research Associates monitor our sites on a regular basis to ensure that the study protocols are being adhered to. Clinical Research Ireland will independently monitor the site and attend Pre-Study Selection Visits (PSSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) and Study Closeout Visits (SCV) on behalf of the Investigator or the Sponsor. Follow up reports are sent to the Site and Sponsor to ensure queries are resolved and information is consistent.
Clinical Research Ireland assists clients to help restore order and ensure the research process is on the right track for successful conclusion.
GCP Standard Operating Procedures (SOPs) Writing
Standard Operating Procedures (SOPs) are detailed, written instructions that describe how to complete and achieve uniformity when performing research-related activities. SOPs are an integral part of Good Clinical Practice (GCP) that are often essential for improving efficiency, communication and training of staff. Our research team understands the value of having well-written procedures in place and can assist clients by writing project specific SOPs for investigative sites that comply with GCP. Alternatively, we can review your existing SOPs to determine their compliance with current regulations and guidelines that govern the conduct of clinical research and recommend additions and revisions if necessary.
Competent Authority Submissions and Ethics Committee Applications
All clinical studies should be conducted in accordance with ethical considerations. Clinical Research Ireland can support Competent Authority and Ethics Committee preparation and submissions. We can provide support for completion of required documentation and submission of a Clinical Trial Application to a Nationally Accredited Ethics Committee for approval. Continuous communication and review is maintained with all appropriate stakeholders through the application stage to prevent unnecessary delays occurring as a result of incomplete or incorrect submissions.
Clinical Research Ireland assists clients collect important data through the use of qualitative and quantitative research methods, including telephone surveys, in-depth interviews and mail, email or web-based surveys.
Connected Health Facilitator
Clinical Research Ireland can act as a connected health facilitator to those in the academic community keen to collaborate with industry experts, or vice versa. Working with a growing network of physicians, hospitals and specialist clinics interested in clinical research, we are able to connect potential collaborators in various therapy areas on behalf of our clients to facilitate study initiation with rapid access to suitable patient populations.