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Brochures & Case Studies

01st Feb 2021

Brochure – An overview of MRN

MRN have the ability to conduct clinical trials wherever the patient is in the...

01st Mar 2021

The Pharma Fast 50 – PharmaTimes Article

MRN were featured in Alantra’s annual ranking of the fastest growing private...

01st Feb 2021

Won’t Someone Think of the Children – International Clinical Trials Article

For too long children have been forgotten in clinical research, but with the...

03rd Sep 2020

Decentralized Clinial Trials – Whitepaper

Running decentralized clinical trials is complex. Especially when "85% of all...

13th Apr 2020

Home Trial Support Talking Points – Journal for Clinical Studies Article

An interview with MRNs CEO Dr Graham Wylie for the Journal for Clinical...

01st Feb 2020

Removing Barriers for Pediatric Patients in Clinical Trials – International Clinical Trials Article

There is a clear disparity between clinical trials conducted on adult...

15th Jun 2018

Community-Based Clinical Trials – The New “Virtual” – PharmaVoice Article

Long recruitment timelines and under-performing sites are the most frequently...

Webinars & Videos

26th Apr 2021

Democratizing Clinical Research – A Personal and Pragmatic View

Session delivered at Clinical Research As A Care Option 2021 Hosted by Doug...

16th Apr 2021

Integrated Solutions to Treating Clinical Trial Patients in the Community

Session delivered at Patients as Partners US 2021 Hosted by Graham Wylie CEO

MRN Timeline

A timeline animation detailing MRNs history

14th Apr 2021

What to expect from a Home Visit

MRN's services are focused on putting the patient at the center of clinical...

Site Professional Support

Our Site Professional Support service is made up of experienced and trained...

01st Apr 2021

The Changing Landscape of Decentralized Clinical Trials

Webinar with Xtalks hosted by MRNs COO Stuart Redding

FAQs

Covid FAQ

What precautions have been put in place for home visits with regards to the Covid-19 pandemic?
1. Healthcare professionals (HCP) complete a rapid lateral flow test prior to every visit, or weekly if they are completing more than one visit per month. HCP can only perform the visit if their test is negative. Test status is tracked and stored by MRN.
2. HCPs contact the subject 24 hours before the visit is to take place to ensure they are still available. At this point the HCP runs through screening questions for COVID symptoms with the patient.
3. Based on national and internal guidelines, MRN has instructed all HCP conducting home visits to follow the following standards:
  1. Aprons, gloves and surgical face masks should always be worn for HTS visits.
  2. Handwashing must be thorough, with water (hot if possible) and soap and last at least 20 seconds. If clean water is not available, use hand sanitizer gel.
  3. Disposable paper towels should be used to dry hands for all visits.
  4. Hand sanitizer gel (or anti-bacterial hand wipes where provided) should be used between handwashes and as you enter or leave the home.
  5. Courier delivery – Per our standard HTS process, the courier driver is not allowed to enter the patient’s home during delivery of IMP or collection of laboratory samples. The HCP will interact with the courier outside the patient’s home and will adhere to the social distancing guidelines whilst interacting with the driver.
How are you ensuring sufficient resources and safety equipment such as PPE where necessary during the COVID-19 pandemic?
1. We are monitoring our supplies vendors closely to ensure that we are aware at the earliest opportunity when essential items might be becoming more difficult to source or when we might experience delays in items being dispatched and delivered to MRN. We have plans in place to ensure, as much as possible, that we are ahead of any potential shortages. We have buffers in place for what we believe to be those items required regularly by HCP who are continuing to support home visits.
How are MRN overcoming the travel restrictions due to the pandemic?
1. MRN and our vendors are following per country National and Local Health Authority Guidance related to travel within impacted regions or where restrictions have been applied. Currently, any travel restrictions do not apply to HCP or services related to delivery of healthcare. MRN has issued HCPs with ‘letters of authorisation’ for travel in those countries where required.
What are the country capabilities in relation to Covid-19?
1. MRN regularly request the below information from vendors:
  1. The current national and local health authority guidance
  2. A description of any variations to their national and local health authority guidance that the vendor is taking
  3. Information regarding vendor resource/capacity that may impact MRN service
2. Vendors provide the requested information and MRN is in regular contact during our normal MRN project management process. Vendors make MRN aware of individual visit or patient issues related to COVID 19 during these communications and the dedicated Vendor Management team are monitoring changes to country restrictions. MRN are also monitoring the global Clinical Trial regulatory bodies information sites to ensure MRN are following all guidance.
3. Specific country updates related to customer ongoing studies can be provided by MRN on request.
Are there currently restrictions to Direct to Patient logistics services related to IMP shipment or sample collections?
1. MRN are working with our logistics partners closely to understand current capabilities per country. Changes are available through website information and through direct contact with vendors as needed. Currently service is being provided with few limitations but with a reduction in national and cross border flights, shipping routes may become restricted and direct drivers will need to be utilized in some situations. Changes in shipping routes may result in unavoidable cost increases per shipment.
Do MRN have concerns about resources to conduct HTS visits during the Covid-19 pandemic?
1. MRN are working closely with our own HCP staff and vendors to understand current capacity and any limitation to service provision. MRN are actively planning back up staff where possible and where national guidelines permit. In our experience HCPs are highly committed to seeing patients and will continue to do so where safe for patient and HCP. Updates will be provided by MRN to customers whose projects are directly affected.

Site FAQ

How quickly are home trial support visits initiated and arranged during studies?
1. MRN recognizes the urgency that the COVID-19 pandemic and travel restrictions have placed on ongoing clinical trials and have received multiple requests for assistance. As a result, we have developed a streamlined approach to evaluating and operationalizing these requests for support. This is a non-standard process that has been developed specifically to address these urgent needs in response to the current crisis.
2. In order to evaluate the viability of Home Trial Support (HTS) for our clients ongoing studies, we will need the following documents:
  1. Request noting that this is COVID-19 Related
  2. Final Protocol
  3. Investigator Brochure
  4. Lab manual
  5. Pharmacy Manual
  6. Master ICF
  7. Study timelines
  8. Status overview of countries/sites/subjects
  9. Specific visits and activities to be conducted for the HTS visit
3. Following a request for support (including the documents listed above), our process begins with a ‘rapid response’ meeting between our SMEs and the CRO/Sponsor to discuss the specific study needs and to ascertain feasibility for HTS services. This rapid response meeting will likely be held 24-72 hrs. after the request is submitted.
4. Following the meeting, and assuming it is feasible to provide the support requested, MRN will develop a working framework and issue a ballpark budget and Letter of Intent (LOI). We expect that process will be completed in 48-72 hours following the meeting.
5. The streamlined approach we have designed is intended to be able to deliver visits within 5-7 weeks (c.f the standard 12-15 week set-up). The achievement of the accelerated timeline is contingent on the sponsor and/or CRO making an immediate commitment based on the ballpark budget and LOI.
6. Due to the dynamic and iterative nature of responding in an urgent manner, we will be unable to provide a full and final budget at the time of the LOI. Our recommendation is to be as pro-active as possible during set-up so that the trial can be set up everywhere that you may need support and prevent the inefficient, and costly, chasing of the impact of the current crisis on your trial.
7. With respect to regulatory issues, it appears that IRB/EC are sympathetic to the need for home visits in order to protect the safety of subjects. To date, we have received no negative feedback from regulatory authorities and ethics committees. However, it will be up to each study team to determine the regulatory acceptability of HTS visits for their study.
8. The accelerated timelines will require the availability of your clinical team to provide timely document review and approval, as needed, during the set-up process
9. Prior to the first HTS visit, we will need a full contract in place
Can HTS be used where previously it was not considered?
1. FDA: Since trial participants may not be able to come to the investigational site for protocol-specified visits, sponsors should evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centres) could be implemented when necessary and feasible, and would be sufficient to assure the safety of trial participants. Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants (for example to carry out procedures necessary to assess the safety or the safe use of the investigational product appropriately); in making the decision to continue use or administration of the investigational product, the sponsor should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach. If scheduled visits at clinical sites will be significantly impacted, certain investigational products, such as those that are typically distributed for self-administration, may be amenable to alternative secure delivery methods. For other investigational products that are normally administered in a health care setting, consulting FDA review divisions on plans for alternative administration (e.g., home nursing or alternative sites by trained but non-study personnel) is recommended. In all cases, existing regulatory requirements for maintaining investigational product accountability remain and should be addressed and documented.
2. EMA: Where a trial participant is unable to attend the site, other measures, such as home nursing, if possible given social distancing needs, or contact via phone or telemedicine means, may be required to identify adverse events and ensure continuous medical care and oversight. However, the limitations and risks of such methods and the requirements for data protection should be considered and such alternative arrangements need to be adequately documented. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
3. UK: If patient visits need to be moved, the options are to set up as a sub-contracted site of the existing site if oversight can be maintained by the existing site, or to set up new sites, or to implement direct home care arrangements by the sponsor. For study types where the addition of new sites is a substantial amendment, existing guidance for submitting a substantial amendment for new sites should be followed. In all other cases, existing guidance for non-substantial amendments and addition of new sites should be followed. https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/

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