Chemical Process Research and Development
How a CRO Can effectively Work with Global Clients
Increasing demands for outsourced solutions has made contract research organizations (CROs) an important facet of the pharmaceutical landscape. Innovator pharma will regularly approach such organizations in order to meet their growing chemistry, manufacturing and controls (CMC) needs. When coupled with the globalization of goods and services, it is common for pharma to work with a CRO whose location could mean your research travels from Cardiff to California, or even Canberra.
For a CRO to efficiently meet the needs of its global customers, it is essential to overcome any logistical challenges. Vastly differing time zones and scheduling could therein prove a difficulty for some. Moreover, companies based around the world will need to comply with differing regulations. However, there are clear strategies that help negate these to ensure optimization through to product launch and life-cycle management.
Update, Upgrade and Upkeep: Regulatory Alignment
Staying on top of the multitude of regulations found throughout the world remains a key part of ensuring efficient business. These evolving regulations across multiple continents ensure it is vital that a CRO develops processes and uses products that comply to the country where its customer is based.
Moreover, simply aligning with one regional regulatory body, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), provides a limited coverage of the global standpoint on many new implemented rules. For example, as China is one of the main suppliers of active pharmaceutical ingredients (APIs) to the EU, it is paramount to ensure both the EMA and National Medical Products Administration (NMPA) are harmonious in manufacturing standards.
A CRO can ensure they remain at the forefront of regulatory information and trends in a range of ways. Attending regular compliance training, seminars and conferences are all essential, while signing up to newsletters and website alerts ensure a CRO stays a step ahead on anything applicable to a client’s business.
The consequences of neglecting the upkeep of regulatory alignment can be incredibly damaging.
Financial penalties and damage to a business’s reputation are two possible consequences, with legal action and external audits also conceivable. Ensuring a partnership with a CRO who navigates the ever-changing environment of global regulations can prove to be crucial to negating potential problems like these.
However, the geolocation of an organization is often not the key variable when it comes to fostering an effective partnership in a global landscape. Typically, an approach to a project will not be influenced by the customer’s location, but instead by the company size and experience and expertise of its staff. Whereas a larger company may require a more streamlined approach, a less mature company with limited experience in a market may require more involvement and support from a CRO. Such support may go beyond technical advice and also include guidance on business development and regulations. The outcomes of such a partnership may vary — they could help to shape a smaller company and refine the capabilities of a larger one.
An important commonality for an effective partnership, no matter the size, experience or location, is communication. A consultative relationship enables a CRO to understand the objectives and challenges faced by a customer. This can be achieved through both the virtual world and real time. Connective tools and advances in digital technology enable instant access and regular updates, in addition to remote access. However, when possible, face-to-face contact can help to ensure that the needs of all companies are met. If conditions allow for physical presence, this can play an important step in building and maintaining client relationships.
Innovation and Location
The transfer of technology is another step that, when optimized, helps to provide an efficient service to global clients, and commonplace in the pharmaceutical industry. In the pharmaceutical industry, this term refers to a manufacturing process dissemination: taking the protocol from a CRO production site and implementing it in a scaled-up facility. This transfer still faces a number of challenges, especially with a global client base, to ensure speedy transitions overseas.
Companies based in different locations will often operate under different technological constraints. A CRO therefore needs to be adaptable and proactive in order to accommodate such differences. With the emergence of new routes to high-value products, promoting rigorous protocol updates is a key enabler to efficiency. Indeed, ensuring protocols are developed thoroughly is a key cost consideration, especially in the early stages of technology transfer. If the transfer of technology is neglected, the results achieved can differ between sites. To ensure that results are reproducible and concerns with cost are eased, a CRO should provide on-site support for the early stages of technology transition.
Worldwide Scientific Excellence
With the exponential growth of the pharmaceutical industry and the lines between CRO and company beginning to blur, the role of a CRO is constantly changing. To succeed in the global marketplace, both CROs and pharmaceutical industries alike are developing new global partnerships. Driven by constantly updated regulations, many companies are now finding a common goal in environmental sustainability, alongside economically viability. No matter the locational or size differences, the pharmaceutical industry speaks the same language — chemistry.
As CROs are increasingly sought after to develop therapeutics that meet the evolving healthcare needs of the world, there is an increasing need for improved connectivity and finger on the pulse of global trends. CatSci, which has a global client base but undertakes the bench chemistry in Cardiff, UK, provides a vivid example of how this can be successfully achieved.