What’s in a name? Quite a lot say CROs and CMOs citing differing business fundamentals

By Gareth Macdonald

- Last updated on GMT

Related tags Clinical trial

An apple, yesterday
An apple, yesterday
The desire to be an all-encompassing ‘one stop shop’ may be common to both contract research organisations (CRO) and contract manufacturing organisations (CMO), but that does not mean the terms CRO and CMO are synonymous say industry leaders.

John Lewis, vice president of clinical affairs at the Association of Clinical Research Organisations (ACRO) told Outsourcing-Pharma.com that - from the research sector’s perspective - running clinical trials and producing drugs on behalf of sponsors are still very different disciplines.

ACRO specifically defines “CRO” as a “Clinical Research Organization” and, to date, none of the major CROs are engaged in contract manufacturing as there are significant differences in the core competencies and business dynamics of research versus manufacturing​.”

However, with ongoing consolidation in this space it is not unforeseeable that clinical research and manufacturing services may be combined under a common umbrella of “contract” services but, at this time, the distinction remains meaningful​. “

Mark Quick, executive vice president of corporate development at Recipharm, is of a similar opinion. He told Outsourcing-pharma.com that distinguishing between the two sectors is a must for CMOs, CROs and indeed the customers they aim to serve.

We believe it is vital to differentiate between a CMO and a CRO in order to give customers a proper picture of the services offered. A CMO may offer clinical trial materials to be used in clinical development, but is most often limited to this part of the development.

Furthermore, the CROs of today very seldom offer manufacturing services. In fact we believe we should also use the expression of CDMO for a company offering pharmaceutical development services in addition to the manufacturing part​.”

Quick also speculated that while contract development and manufacturing organisations (CDMO) - like Recipharm - and counterparts in the CRO sector may collaborate more closely in future, the terms used to characterise such partnerships are still to be defined.

 “We may of course also see further integration where CDMOs and CROs merge to be pharmaceutical contract providers. It remains to be seen how we shall name such companies but for the time being CMO and CRO definitely has a separate meaning in their own right​.”

Almac spokesman ​Jonathan Calderwood has a different take. He told Outsourcing-pharma.com that: “Many service providers are adding activities to their portfolio that do not sit easily within a "two box" definition.

Yet despite such expanded offerings - Calderwood continued - companies still define themselves as either a CRO or a CMO.

The range of disciplines within the clinical development world are numerous and contractors tend to assemble their portfolios closely around their core market strengths​.”

So it seems that – for the foreseeable future at least – the terms CRO and CMO need to remain separate for the good of contractors and pharmaceutical industry customers.

Related news

Show more

Related products

show more

Unlock potential in buffer preparation

Unlock potential in buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 18-Sep-2023 | Infographic

Consider how the right partner can help you scale faster, mitigate risks, and optimize resources.

Plan for success with process liquid and buffer preparation

Plan for success with process liquid and buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 14-Aug-2023 | White Paper

Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated...

Automated metadata management in clinical trials

Automated metadata management in clinical trials

Content provided by Formedix | 01-Aug-2023 | White Paper

When it comes to efficient clinical study build, content is king. Most importantly: metadata content. In this blog, we explore the role of metadata in...

Validate clinical study data with Formedix CORE

Validate clinical study data with Formedix CORE

Content provided by Formedix | 19-Jun-2023 | White Paper

In April 2023 at the CDISC Europe Interchange, we launched Formedix CORE, the first free-to-use, downloadable application encompassing the CDISC Open Rules...

Related suppliers

Follow us

Products

View more

Webinars