MRN specializes in the conduct of clinical trial visits in the patient’s home and supporting clinical trial sites with nursing resources. At MRN we understand the complexities of today’s clinical trial environment and the burden this places on both patients and sites. Our nursing services are designed to ease these burdens, therefore accelerating patient recruitment and retention and maximizing the impact of the trial for the pharmaceutical sponsor.
Our partnering model enables us to provide research nurses in more than 40 countries worldwide. We work with a network of both large and small partners, or employ nurses directly where required for a specialist study, creating nurse teams almost anywhere in the world.
Home Trial Supportis the conduct of clinical trial visits in the patient’s home. This replaces a number of protocol defined visits which would normally take place onsite, and relocates them in the patient’s home – reducing the burden of the trial on the patient and significantly boosting patient recruitment and maximizing patient retention.
Site Nurse Supportplaces experienced research nurses into sites to manage trials; this enables each site to focus on patient identification and selection, as well as facilitating performance of all procedures in a timely manner. Placements can be made at single sites, or nursing teams can be pulled together to support sites across whole countries or trials.
MRN specializes in COMPLEX clinical trials. From studies in oncology, pediatrics or rare diseases, to IMP administration in the patients’ homes and global trials, our solutions are designed to make complex clinical trials simple to conduct.
We are highly experienced in complex drug administration in the home. The IMP is carefully assessed by our medical and nursing team through review of the Investigator Brochure and discussion with Sponsor research and development and medical teams, in order to recommend which visits can be conducted in the home and which in the clinical sites. We create a home healthcare treatment regime that is attractive to both patients and Investigators, which when offered to patients during the consenting process, leads to dramatically increased patient recruitment rates.
Enrolling children into clinical trials is one of the most pressing, but also the most difficult tasks facing therapeutic research and development teams. Children, perhaps more than any other group, need medical care to cause as little disruption as possible to their education and everyday life, and instil a sense of security. We can provide experienced homecare nurses to conduct clinical trial visits at home, school or college, as long as basic facilities are available. We can also conduct visits in the evenings or at weekends making the clinical trial convenient for patients, parents and carers.
Orphan and Rare Diseases
Clinical trials for orphan and rare disease drug indications are notoriously difficult to recruit into and often require more invasive interventions than traditional therapy. However, adopting home healthcare in rare disease clinical trials drastically improves the quality of life for patients and makes them accessible to patients who may otherwise have to travel large distances to clinical sites.
Providing home healthcare for global multi-center trials is one of MRN's specialities. We have the largest network of nurses globally, covering over 40 countries. Our unique IT, electronic data capture (EDC) and transfer and training systems enable us to start-up large teams of nurses quickly and efficiently, almost anywhere in the world, tracking all visits remotely and in real time.
Home Trial Support provides a number of benefits for sponsors and CROs, clinical research sites, and most of all, the patient.
For the patient, their families and carers:
For the clinical research site:
For the Sponsor and CRO:
Providing a patient-centric model through Home Trial Support clinical trials gives Sponsors and CROs:
How do we train our nurses?
We only use nurses who have previous experience in conducting patient visits at home; these nurses are trained in the specific therapeutic area, the protocol and the study requirements, as well as ICH GCP.
Training is conducted either at the beginning of the study, or as nurses are allocated to patients on a just in time basis. Nurses only complete home visits once they have completed and passed the study specific training.
Training can be completed face-to-face or online. MRN–TEC is our online nurse training and documentation portal, which ensures we can deliver nurse training rapidly to large teams across the globe in their local language. The nurses can log in to the MRN-TEC portal and take part in the training at a time to suit them, making it an ideal solution for global trials working across a number of time zones. All training includes competency testing, which makes it robust and unique in our sector.
How is data reported to sponsors?
Our nurses complete source documents (Visit Report Forms) in the patient’s home using electronic pens. All documents are printed on specialized dot matrix paper, which allows the pen to record the co-ordinates of the pen strokes as the document is completed; once the pen is docked, the co-ordinates are uploaded to a secure portal where site staff can view a PDF image of the source document. Once this has occurred the visit is automatically logged as completed in MRN’s reporting tool MRN-SMART.
Your CRA’s can monitor the source data Visit Report Forms as standard, either by logging in to MRN-SMART to review the data electronically, or by reviewing the hard copy wet ink version that is sent to site by the nurse.
MRN-SMART can produce standardized reports of scheduled and completed visits, as well as Sponsor customized reports that are available to both Sponsor and CRO personnel, via secure login to the portal. This, coupled with regular formal team meetings and teleconferences, ensures the Sponsor has visibility to study progress at all times.
How is quality maintained?
MRN has developed a bespoke quality management system, MRN-COMPLY, that defines how the business is managed and how our trial activities are undertaken.
MRN-COMPLY is made up of our unique document suite, including: ~20 Standard Operating Procedures (SOPs), ~100 guidelines, policies and ~200 templates, which have all been developed to ensure regulatory compliance and best practice in the delivery of nursing solutions. Our processes are reinforced with quality gates, ensuring managerial and peer review steps are defined to maintain quality at all times.
We also run strict governance programs across our nursing services and the management of our nursing vendors.
We have dedicated internal quality and training managers to ensure our training is robust and our processes adhered to.
Headquartered in the UK with offices in the US and Spain. Our Vendor Contracts and Management Team (VCMT) have enabled us to conduct home clinical trial visits across all major clinical research countries spanning North America, Europe, Asia and Australasia