A safe clinical trial presupposes a robust supply chain management of the study drugs, consistent with various regional and global regulations and available infrastructures. Clinical trial supplies management is imperative for avoiding overproduction, inventory expiration, and oversupply. With the escalating costs of drug discovery, clinical trial supplies is gaining more significance. In addition, the implementation of stricter handling requirements for a variety of biopharmaceutical products entering clinical trials, clinical trial supplies strategy needs to be constantly overhauled. This also calls for integrating several third-party vendors across all stages of clinical development.
Sponsors and contract research organizations partaking drug discovery initiatives have realized the role of clinical trials logistics and end-to-end solutions for respecting the desired study timelines. Stringent handling requirements pertaining to the handling requirements such as good manufacturing practices (GMP) are essential for the manufacture, storage, and distribution of investigational medicinal products (IMPs), essentially for clinical trials being conducted in developed regions such as Europe and North America.
Activities related to import and distribution of IMPs and Non Investigational Products (NIMPs) also mandate an extensive clinical trial supplies planning for adhering to require trial protocols. These also include standardized return and destruction procedures. The increasing prevalence of chronic diseases such as various cancer types and the growing popularity outsourcing of drug discovery services, in several developing and developed nations, is expected to bolster the demand for clinical trial supplies services. In addition, the rising need for determining the level of toxicity in the early stages of drug discovery is a crucial factor catalyzing the Clinical Trial Supplies Market.
Clinical trials are research studies that discover whether a medical treatment, strategy, or device is effective and safe for humans. There are four stages of clinical trials: phase Ι, phase ΙΙ, phase ΙΙΙ, and phase ΙV. Identification of pharmacological actions and tolerability is done in phase I. Phase ΙΙ evaluates drug safety and efficacy. Phase III involves the evaluation of risk benefit ratio and determination of dosage interval. Epidemiological data, efficacy, and safety within large diverse populations and pharmacoeconomics are identified in phase IV.
Clinical trials are complex activities that require synchronization of several different functions and processes. A pharmaceutical manufacturer’s primary goal in any clinical study is to optimize clinical trial supplies so that packaged investigational materials are distributed to patients enrolled in a clinical trial on time. These activities include, but are not limited to, project management, clinical packaging, randomization generation, labeling, supply chain logistics, blinding, distribution, return drug accountability, and destruction.
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The clinical trial supplies market can be segmented based on products and services, therapeutic area, and region. In terms of products and services, the market can be categorized into manufacturing, packaging, logistics, and distribution. Based on therapeutic area, the clinical trial supply market can be segmented into oncology, cardiovascular diseases, neurological diseases, respiratory diseases, orthopedics, and others. In terms of end-user, the market can be segregated into contract research organizations, pharmaceutical & biotechnology companies, academic & research institutes, and others. In terms of region, the market can be divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
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