Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Can anyone direct me to expert advise, opinions, experiences, and references that address the question about using or not using CROs for medical device clinical trials?  Is using in-house resources a better idea in the end?

Thank you!

Original Message:
Sent: 5/12/2023 3:58:00 PM
From: Anonymous Member
Subject: Pros and cons of using CROs or in-house resources for medical device clinical trials

This message was posted by a user wishing to remain anonymous

Can anyone direct me to expert advise, opinions, experiences, and references that address the question about using or not using CROs for medical device clinical trials?  Is using in-house resources a better idea in the end?

Thank you!

As Ted mentioned, if you don't have your QMS setup to address GCP or ISO 14155 it will take quite a bit of work to get that in place. As such, I would recommend you utilize an external CRO. Especially if you are only going to run a few studies and it is not work the investment in resources to develop your QMS for GCP or ISO 14155.

If you are considering an external CRO you should consider the following which are excerpts from a blog my company will be publishing in the the coming weeks:

A reliable CRO should have a quality management system (QMS) in place to meet the requirements of ISO 14155, Clinical Investigation of Medical Devices for Human subjects – Good Clinical Practice (GCP). Its staff should be well-versed, trained, and certified on the standard and must implement it daily.

Geographical Expertise

CROs should have expertise in the geographical area of the trial as well as the disease to be studied. 

Relationships

It is valuable to select a CRO with access to many investigational sites with experienced research staff and the potential for high enrollment rates. Choosing a CRO with multiple contacts fully committed to your needs as the Sponsor is highly beneficial.

Technologically Savvy

An experienced CRO can offer services for single-site and multi-site investigations, such as regulatory support, study and site start-up logistics, site management, monitoring, data management, medical device vigilance, biostatistics, report writing, and overall project management. It would help if you also looked for a group with strong technological capabilities that optimize study management and guarantee data quality.

Specific Characteristics

When interviewing a CRO, you should be looking for the following characteristics among staff members:

·         Multi-Disciplinary

·         Curious

·         Empathetic

·         Critical Thinkers

·         Ethical

·         Honest

·         Flexible

·         Great People Skills

Track Record

There is a wide variety of global CROs who all have different expertise. Some CRO groups are privately owned and funded, while others are publicly held companies. When comparing one organization to another, you must look at each company. Do both companies have similar expertise, budgets, timelines, and overall experience? Which company do you find to be more flexible, curious, and empathetic? 

------------------------------
Wade Munsch
Regulatory Affairs Manager
Biotex, Inc.
Houston TX
United States
Company Website: www.biotexmedical.com
Test Lab Website: https://www.biotexmedical.com/criterion/
------------------------------

Original Message:
Sent: 12-May-2023 15:58
From: Anonymous Member
Subject: Pros and cons of using CROs or in-house resources for medical device clinical trials

This message was posted by a user wishing to remain anonymous

Can anyone direct me to expert advise, opinions, experiences, and references that address the question about using or not using CROs for medical device clinical trials?  Is using in-house resources a better idea in the end?

Thank you!

Hi Anon,

If you are opting to outsource your trial, I would recommend to look for CRO's that have experience with medical device trials. And you may further want to select for therapeutic area. There are niche CRO's that specialise in fields that very closely align with your target population of patients and clinicians. You may also want to consider selecting a CRO that fits your company's size and culture. For example, if you are a start-up company I would not go for one of the CRO giants out there. During the CRO selection process also evaluate whether the CRO will be subcontracting work and how they control their subcontractors (freelance monitors for example). When you outsource, you should still have a high level clinical investigation procedure and you will want to cover the vendor selection and vendor management. You may want to audit the CRO and the study (see also ISO 14155 Annex J on Clinical Investigation Audits). Ultimately, as the Sponsor you are responsible for what happens during the study. Make sure you have a dedicated and experienced project manager on your side to work with the CRO. Be aware of the financial risks, make detailed agreements with the vendor and make sure the project manager is on top of the budget at all times. Reserve sufficient budget to cover project management and communication with the CRO (the CRO will invoice you for every minute spent on calls). You can insource the study, but as said by others this requires a big QMS infrastructure and specialised personnel. Hybrids are an option, where your team splits tasks between them and the CRO. The statement of work will need to detail who is responsible for each task. In any scenario, communication is key to success. 

Best wishes, Wiebe

------------------------------
Wiebe Postma
Vierpolders
Netherlands
------------------------------

Original Message:
Sent: 12-May-2023 15:58
From: Anonymous Member
Subject: Pros and cons of using CROs or in-house resources for medical device clinical trials

This message was posted by a user wishing to remain anonymous

Can anyone direct me to expert advise, opinions, experiences, and references that address the question about using or not using CROs for medical device clinical trials?  Is using in-house resources a better idea in the end?

Thank you!

Hello,

My personal recommendation is to find experienced freelancers or a network that offers access to such freelancers and work with them. It will be cheaper and will allow you to have better oversight on what is happening on the study. Once you outsource your study you are not much in control what is going on even if you have regular calls with CRO management. 

Good luck!
Olga

------------------------------
Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
olga.peycheva@solutionsop.co.uk
United Kingdom
------------------------------

Original Message:
Sent: 12-May-2023 15:58
From: Anonymous Member
Subject: Pros and cons of using CROs or in-house resources for medical device clinical trials

This message was posted by a user wishing to remain anonymous

Can anyone direct me to expert advise, opinions, experiences, and references that address the question about using or not using CROs for medical device clinical trials?  Is using in-house resources a better idea in the end?

Thank you!