A Contract Research Organization (CRO) aims to provide clinical trial management services for industries dominating in fields like pharmaceuticals, biotech, and medical devices. There are different types of CROs that offer different levels of specializations.

Reasons You Should Partner with a Bioanalytical CRO

Bioanalytical studies are an integral part of biological drug development. Data attained through these studies and analysis serves to define the core characteristic of the potential new biologic. In clinical research and trial, bioanalytical laboratory services assess different aspects of the drug and its characteristics.

In today’s time, there is a rapidly growing demand for products to reach the market to satisfy needs and to fight off growing competition between biotech and biopharma companies. So, to make a mark in the industry and cater to these growing demands, partnering with bioanalytical companies that offer expert and excellent bioanalytical laboratory services is becoming extremely important.

Limited budget and resources

Bioanalytical studies require most work to be conducted under Good Laboratory Practice (GPL). It means that the in-house analytical lab must comply with rules and regulations as laid down by the regulatory bodies. To do so, the company must have a top-quality system built in place, with accurate and regular auditing, proper documentation and records of the facility, and more.

It would be impossible for smaller biotech companies who function with a limited operational budget to have the most refined system and equipment that adhere to the GPL quality laboratory benchmark. It would also be difficult for bioanalytical companies in general. Therefore, a more accessible and more beneficial option is to partner with CROs that offer assistance in such conditions through their bioanalytical services.

Lack of Equipment and Capacity in in-house labs

Despite the best efforts, an analytical lab may not be up to par regarding equipment and experiences that expert bioanalytical CRO may be able to provide. It would be economical and beneficial for smaller biotechs to partner with these CROs and continue with their bioanalytical laboratory services.

When the in-house lab for the biopharma or biotech company is deduced as lacking in a capacity that is required for better turnarounds, outsourcing the work to a partner bioanalytical lab would become unavoidable. Hence, partnering with a bioanalytical CRO that offers inclusive assistance for these various industrial drawbacks could be marginally effective and beneficial for biotech companies.

Effective And Accountable

Partnering with a bioanalytical CRO will grant your biotech company to attain assistance and gain from their already established quality system to help attain operational excellence and better turnarounds. It will help in processes starting from discovery and development to clinical trials, sample preparation, validation tests, and data presentation to the authorities and other regulatory bodies. CROs also provide services in Bioanalytical assays, Pharmacokinetic (PK) and Toxicokinetic (TK) studies.

Partnering with CROs that have expertise in bioanalytical fields can play a pivotal role for smaller biotech companies. CROs offer expert consultation and valuable services with the help of their evolving understanding of the field.

Bioanalytical services are essential for deciding the estimates of the concentration for the new biologics in its clinical research and trial stage and play key roles in regulatory filing affairs and other nonclinical studies that require concentration info for other important branches like pharmacokinetics, biomarkers, or toxicokinetics.