Medial Research Network

Expedited Start-Up (ESU) FAQs

1. What are your plans to manage studies during the pandemic?

In these very challenging times, we remain committed to providing the services our customers need in this dynamic environment. As we are accustomed to providing bespoke services for unusual situations, we can shift services to areas of lower risk where needed. However, please remember that despite our decentralized approach, we are not immune to the effects of COVID-19 and the ability for us to fully support trials is limited by our nurse availability, which will vary by city, country and region, based on the pattern of virus spread. 

We are working with our internal nurse network and approved vendors to ensure that the Home Trial Support Professionals performing home visits take the relevant precautions to protect themselves and their patients.

Unfortunately, some personnel may not wish to see patients located in certain areas, and we cannot enforce this, so we will work with our partners to provide alternative personnel. 

2. In your view, which type of study should be prioritized for Home Support Staff?

Our clients are seeing the need to move to a more home-based monitoring model to protect their trials and the patients. This is leading to an increase in requests for Home Trial Support.
 
In order to cope with increased demand and ensure that we can deliver on projects won, MRN will be prioritising those studies that we have the greatest chance of helping. This means that we will focus on requests where we are asked to:

             1. Ensure support for the whole trial
             2. Look after patients already in the trial.
 
MRN will help the most if we support the whole trial - i.e. all countries within our capability and all sites (this should include those countries that are under the greatest pressure).  Supporting the trial ONLY in countries under lockdown already is not ideal. This will allow us to do our best to support those patients in dire need AND to move recruitment around the countries and sites less affected to enable the study to complete successfully.
 
These trials will be prioritised in our triage process. Requests for support in limited countries, particularly just those in lockdown only, will get placed low down the priority list or maybe declined entirely.
 
In this manner, we will be able to assist the most clients, in the most efficient and successful manner possible.

3. Should we prioritize any patient population based on your experience?

Our clients are seeing the need to move to a more home-based monitoring model to protect their trials and the patients. This is leading to an increase in requests for Home Trial Support.
 
In order to cope with increased demand and ensure that we can deliver on projects won, MRN will be prioritising those studies that we have the greatest chance of helping. This means that we will focus on requests where we are asked to:

             1. Ensure support for the whole trial
             2. Look after patients already in the trial.
 
MRN will help the most if we support the whole trial - i.e. all countries within our capability and all sites (this should include those countries that are under the greatest pressure).  Supporting the trial ONLY in countries under lockdown already is not ideal. This will allow us to do our best to support those patients in dire need AND to move recruitment around the countries and sites less affected to enable the study to complete successfully. 
 
These trials will be prioritised in our triage process. Requests for support in limited countries, particularly just those in lockdown only, will get placed low down the priority list or maybe declined entirely.
 
In this manner, we will be able to assist the most clients, in the most efficient and successful manner possible.

4. How soon can you send a nurse into the home?

MRN recognizes the urgency that the COVID-19 pandemic has 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. 

In order to evaluate the viability of Home Trial Support (HTS) for our clients' ongoing studies, we will need the following documents:

• Request noting that this is COVID-19 Related
• Final Protocol
• Investigator Brochure
• Lab manual
• Pharmacy Manual
• Master ICF
• Study timelines
• Status overview of countries/sites/subjects
• Specific visits and activities to be conducted for the HTS visit

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. 

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.

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.

Due to the dynamic and iterative nature of responding in an urgent manner, we will 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.

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.

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.

Prior to the first HTS visit, we will need a full contract in place.

 

Other FAQs:

- Country Coverage FAQs

- General FAQs

- Home Trial Support (HTS) FAQs

- Supplies FAQs

COVID 19 FAQs
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