Science and Innovation

Clinical Trials

At the start of any new drug development is an understanding of a disease, the discovery of a medication and a choice of the most active substances to provide relief or prevention. It takes two to three years for a medication to be created.

What is a clinical trial?

What is a clinical trial?

A clinical trial (also called clinical study) is designed to make sure a compound is safe and effective to be used by humans. It takes place after in vitro and animal studies have proved satisfactory.

The compound, also called investigational product, is compared either to a placebo (a substance with no pharmacological activity) or to existing treatments, to decide if it is more or less effective.

The clinical trial determines the effective dose, possible toxicity and the nature and frequency of undesirable side effects.

Pacific Vital Inc. supports a wide range of partners worldwide, particularly in the dietary supplement, personal care, and pharmaceutical industries. Many people take various forms of dietary supplements to boost health and well-being or address deficiency symptoms. For nutritional supplements to achieve their desired effect, their composition and exact dosage of the active ingredient is essential.

As an experienced player with dedicated labs in nutritional supplement testing, we not only determine the exact composition of your product’s active ingredients but further test them for possible unwanted residues or contaminants. Also, we can provide you with qualified and dependable advice regarding the production of your nutritional supplements.

Microbiology

Microbiology

Microbiological analysis is one of Pacific vitals’ “bread and butter” operations. Since its genesis in 2000, ARL has built its success around testing accuracy and on-time reporting. We offer BAM, AOAC, and USP methods, including USP 2021/2022, USP 51, USP 61/62, and USP 71. We have the experience to help you select the most appropriate method for your product and determine your acceptance criteria. Our expertise will add another level to your quality control and quality assurance programs. No matter your quality objectives, ARL’s team will help you achieve success.

Environmental Monitoring

Environmental Monitoring

Environmental Monitoring (EM) is crucial to mitigating risks in your facility. Analytical Resource Laboratories has the expertise to assist you with developing and implementing your EM program and validating your cleaning processes.

Based on these and other questions, our company can formulate a detailed plan that will help you meet your quality objectives. Our services include contract manufacturer, samples, worldwide sourcing, running inventory program, fast delivery service, logistics, warehousing, provide all technical documents and lab testing.

Stabilities and Shelf-Life

The stability and integrity of your products over time are crucial to your product brand. Our Company offers both Real-Time and Accelerated Stability and Shelf-Life studies to provide you with data to support your best by or expiration dates. Contact our Samples Management Team or Partnerships Team for more information and a detailed quote on services, pricing, and testing intervals. Simply provide us with a copy of your product label, and together we will explore your options. We will help you every step of the way.

Stabilities and Shelf-Life

Stabilities and Shelf-Life

The stability and integrity of your products over time are crucial to your product brand. Our Company offers both Real-Time and Accelerated Stability and Shelf-Life studies to provide you with data to support your best by or expiration dates. Contact our Samples Management Team or Partnerships Team for more information and a detailed quote on services, pricing, and testing intervals. Simply provide us with a copy of your product label, and together we will explore your options. We will help you every step of the way.

Instrumental Analyses

Analytical testing results are only as good as the equipment and methods used. Highly trained scientists dedicated to quality and accuracy, using validated methods, are essential to our success. Pacific vital’s strict adherence to Good Laboratory Practices, ISO Accreditations, and robust quality training of our team members are the keys to generating accurate and reliable results. We employ state-of-the-art analytical equipment such as HPLC, GC, GC-MS, ICP-MS, PCR, and more, all under preventative maintenance schedules, which help us maintain consistent and reliable turnaround times and accuracy.

Why are clinical trials necessary?

Clinical trials are a mandatory part of the process of a drug being approved for marketing. Before new treatments can be made available to all potential patients, we must make sure they are effective and safe. Clinical trials are used to validate new treatments but also to define the patient groups they must be used for. Finally, clinical trials help to better understand the characteristics of a disease.

What are the criteria for the decision to launch a clinical study?

After researching a compound, labs test it in vitro and then on animals. These steps evaluate the compound’s effectiveness and tolerance. If all the data is satisfactory, the next step is to consider tests on humans. The pharmaceutical manufacturer then submits a request to an Independent Ethics Committee (IEC) or Institutional Review Board (IRB), a completely independent organization whose job is to monitor the test procedures. Once the committee approval is obtained, the clinical trial will proceed but the participants’ safety has to be kept in mind throughout the process.

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