Why Outsource Bioanalysis Work?

When considering whether to outsource work to a CRO, there are several factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

FREMONT, CA: A sponsor may decide to outsource some or all of its bioanalytical work as medicine progresses through the research and regulatory pipeline to approval for a variety of reasons. Some biopharmaceutical enterprises could be virtual and require complete outsourcing. Others may be capable of performing the work internally, but they opt to outsource for tactical or budgetary reasons. When a sponsor picks a contract research organisation (CRO), some are looking for a collaboration, while others may only need the CRO's services for a single project, in which case the connection is purely commercial. Whatever the circumstance, a sponsor should take into account its requirements, potential, expectations, and constraints when selecting a bioanalytical CRO. CROs can provide a wide range of services besides bioanalytical, including managing clinical trials, running centralised lab operations, manufacturing, etc. There are CROs that just offer services related to bioanalysis. Some people might have specialised assay equipment or be experts in a certain therapeutic field. Some will be better suited for lengthy, high-volume clinical trials, while others will be better suited for pre-clinical development research. While some bigger CROs may be hesitant to commit to smaller research that could conflict with their commitments to major studies, small CROs might not be able to handle many large-scale investigations while simultaneously supporting other customers. The selection of CRO in this instance is then limited.

Several labs may be needed for various stages of drug development at various times. To support investigational new drug (IND) submissions and clinical trial design, pre-clinical research is required. To guarantee the accuracy and dependability of the data, bioanalytical good laboratory practice (GLP) studies are intended to be carried out with the appropriate quality measures in place. A therapeutic's companion diagnostics may also be produced in conjunction with exploratory biomarker assay determination to narrow the field for future clinical endpoints. When selecting a CRO for early development research, elements to take into account may include the ability to fulfil strict deadlines as well as the potential for forming a partnership for clinical studies given the necessity for quick data turnaround for decision-making purposes. Phase III investigations to first-in-human (FIH) trials are all a part of clinical development. Regulations governing good clinical practice (GCP) make bioanalytical programmes more complex, and they frequently use a central laboratory to process samples. Pharmacokinetic/pharmacodynamic (PK/PD), anti-drug antibody (ADA), and biomarker assessments, as well as the utilisation of a cell culture facility for neutralising antibody (NAb) assays, are examples of bioanalytical techniques. Safety and efficacy data for regulatory agency submissions as well as medical device application data for companion diagnostics are regulatory issues for clinical development.

Clinical trials can be extensive, extend for years, study a variety of groups, and involve tests for genotoxicity, reproductive toxicity, and carcinogenicity. Long-term sample storage and assay lifecycle maintenance for essential reagents are additional factors to take into account along with bioanalytical assay development, validation, and sample analysis. For clinical investigations, factors to take into account include selecting a CRO with the ability to create, validate, and analyse high-throughput studies following regulatory advice and the stability to support the requirements of longitudinal research.