Outsourcing is the new modus operandi of the pharmaceutical industry. A large number of labs and Contract Research Organizations have sprung up to handle various requirements of the industry. Like any other niche, these companies vary in size.

Some CROs are behemoths with revenues in the billions and operations in several countries. Smaller CROs don’t match these numbers but continue to offer excellent services. At first glance, this seems like a David vs. Goliath scenario but believing that would be barely scratching the surface.

Cost is an obvious factor here. Large CROs have more resources, and big sponsors have the money to afford them. However, the general view in this area is changing. Boutique CROs are full of experts, and companies certainly won’t mind their input. There is no dearth of talent in large companies either, but there is an implied red tape of larger organizations.

Method Development Basics – Does Size Affect Method Development?

Signing a contract and setting a Standard Operating Procedure (SOP) both go hand in hand. This document sets up various parameters of the study, including method development and validation. But does the size of the company signify a change in method development or validation?

There is no real difference as far as the process is concerned. A large CRO can provide resources faster and move quicker on the process. But then again, it could be stalled by company bureaucracy.

A boutique lab has a smaller staff and comparatively limited resources. However, they can put greater focus on client needs. Rather than a low or mid-level employee of a big CRO, the sponsor would likely deal with top-level executives directly in a boutique CRO.

A boutique lab may be better positioned for handling method validation. While their funds and staff may be small than a large CRO, boutique labs often have immensely experienced and competent professionals running things.

A large CRO, too, has no dearth of talent. However, a boutique lab can afford to be hyper-focused and play entirely to its strengths.

The relationship between a sponsor and CRO is no longer a project-by-project deal. Instead, it is very much a long-term relationship that presents more as a strategic partnership. Often, the expectation goes beyond just handling technical and scientific data, and also encompasses the realms of the regulatory requirement.

Method development and validation are important to the whole process, especially with regulatory requirements. Smaller companies will often rely on their “strategic partner” to assist with regulatory requirements. Sometimes, the boutique lab may also find itself handling filings or general hand-holding of the sponsor. Where accessibility, communication, and interest in a project are concerned, the boutique northeast bioanalytical laboratories is tough to beat.

The Playing Field is Leveling

While access to greater resources remains an asset, the playing field is leveling for the large CRO and boutique lab. Scalable software is reducing costs. Following flexible processes has also proven to be immensely useful.