Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As these products must undergo extensive testing before being approved for the public, gathering high-quality, reliable and statistically sound data is an important goal for all clinical research. There are, however, converging trends challenging the ability of legacy data management systems to establish and sustain data integrity throughout all phases of clinical studies…
For Release: July 29, 2019, Springfield, Massachusetts
Just a few short years ago, the clinical toxicology laboratory space was filled with startup laboratories often managed by folks with little to no experience in the field. Such labs often did not have the years of experience and highly efficient processes of larger, more sophisticated laboratories. And their billing and payment collections processes were lacking as well.
Their selection of a laboratory medical billing and Revenue Cycle Management (RCM) vendor was often decided based upon short internet searches of local medical billing companies. The issue, however, was that most of these companies were physician billing companies with little to no background or experience when it comes to laboratory billing (or specifically, toxicology laboratory billing), and had limited technical expertise (required for creating optimized electronic work flows) or prior history in scaling a billing company to handle the high volumes of very specialized claims produced by such laboratories. As these companies started to grow along with the industry, they were able to secure the business of some of the larger laboratories.
The performance of virtually all of these companies was sub-par by professional laboratory billing standards. So why would labs keep them?
Cloud computing is the 21st century’s version of the industrial revolution. In the last decade, cloud computing and associated software as a service (SaaS) products have experienced massive growth and adoption. The enormous increase in computing power accessibility that cloud technologies provide are helping to fuel a revolution in innovation and worldwide economic growth. Entire industries are being transformed as the cloud spawns new apps, products and services that are changing the way we live, work and play.
The chances for a drug candidate entering a preclinical trial to eventually pass the FDA approval stage and make it to market are exceptionally grim – only 1 in 5,000 successfully complete the journey. Additionally, the entire process of bringing a new drug to market takes roughly 12 years on average, while the US Department of Health and Human Services has estimatedthat it costs somewhere between $161 million and $2 billion to bring a new drug to market.
Most laboratories can readily see the value in the deployment of Laboratory Information Management System (LIMS) or a Chromatography Data System (CDS), but what about a Scientific Data Management System (SDMS)? Many companies feel confident that instrument data from the laboratory is protected in each instrument system (CDS, UV, IR, Mass Spec., etc.) and then…
July 24, 2019 - Live Webinar: Role of LIMS in Overcoming Biorepository Operational Data Management Challenges
CloudLIMS is pleased to host a complimentary live webinar titled “Role of LIMS in Overcoming Biorepository Operational Data Management Challenges” on August 13, 2019, at 5 P.M. GMT (1 P.M. EDT). The webinar will be presented by Dr. Steven Haynes.
To read the complete blog, please visit: https://cloudlims.com/blog/webinar-role-of-lims-in-overcoming-biorepository-operational-data-management-challenges.html
Cannabis (aka hemp or marijuana) is a wind-pollinating genus of flowering plants in the family Cannabaceae. This complex plant contains a group of chemicals known as cannabinoids, many of which have shown significant biological activity. Two cannabinoids in particular, cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), have gained much recognition for their mental and physical effects when consumed. To date, over 100 different cannabinoids have been isolated from cannabis plants, and these compounds are generating significant interest in the pharmaceutical industry for potential drug and biologics production. Cannabis Testing Labs must implement the right processes to keep pace with regulation and innovation.
In today’s global economy, scientific organizations in many different industries are turning to collaboration with external partners to fuel their R&D pipelines with flexible networks of researchers. These external collaborations can take many forms – research institutes, industry and academic partners, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), external testing laboratories, consortia, etc.
Many organizations combine numerous partners in diverse ways across multiple research projects. Even in simpler models, any collaboration with an external partner is typically not static, but evolves over time. Therefore, sponsoring organizations are often changing the business processes around the collaboration frequently and rapidly.
The U.S. Food and Drug Administration (FDA)recently announced plans to update theDietary Supplement Health and Education Act of 1994 (DSHEA). The potential DSHEA changes have prompted concerns about the business impacts of additional regulatory rigor. To be ahead of the competition when changes occur,nutraceutical manufacturers should consider implementing aLaboratory Information Management System (LIMS),which can addressmany of the concerns.Also, consider therisks related to notimplementing a LIMS: analyze the monetary, time, and opportunity costs of maintaining your status quo. Compliance is often easier and less expensive with a LIMS.Before we get in to the specifics, let’s look at the background of these regulatory changes.
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How QLIMS supports the medicinal cannabis process
As the cannabis testing industry grows more and more, so does the need for greater efficiency relating to results, reports, regulatory compliance and the many other aspects of data management.
Here we will explain to you how our solution, QLIMS, supports companies involved in each part of the chain and the items that medicinal cannabis companies should consider when selecting a LIMS and software for quality control. [Read More]
Drug discovery is a challenging endeavor. The first step – finding compounds with the desired medicinal effect on the target pathogens – has traditionally involved the automated high-throughput screening of large compound libraries to identify “hits” with biological activity. Once identified, promising compounds are put through a process called lead generation to evaluate criteria such as their dose-response curve, cellular efficacy, affinity towards the target, reactivity with other compounds, cytotoxicity, etc.
Of all the functionality offered by modern LIMS, accurate acquisition and reporting of test results is a central requirement. There are essentially two ways to enter results data into the LIMS – manually or directly from the testing instruments. Entering results manually is clearly quite common, but offers the possibility for transcription errors, especially if the results are first written down in a notebook and then later typed into the LIMS. Direct integration of instrumentation into the LIMS eliminates this possibility and helps meet data integrity and validity requirements. This is particularly important in the pharmaceutical manufacturing industry, where data integrity is critical throughout the cGMP (Good Manufacturing Practice) data life cycle. Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).
In today’s fast-changing and fast-paced business environment, having an accreditation is critical to your business – but it can also be time consuming and onerous, and failing on something like accreditations can be unfavorable to your business.
Discover how STARLIMS Laboratory Information Management System (LIMS) can support your efforts around ISO 17025, both in achieving and in maintaining your compliance and in helping to relieving the accreditation burden.
DOWNLOAD THE INFOGRAPHIC TO LEARN:
- What ISO 17025 is and why this accreditation important
- What’s new on ISO 17025:2017?
- Advantages of achieving this certification
- How STARLIMS can support your efforts around ISO 17025:2017 accreditation
The Food and Drug Administration (FDA) is tasked with protecting the public health by ensuring the safety, efficacy, and security of the nation’s food supply, human and veterinary drugs, biological products, medical devices, vaccines, and other products. In order to fulfill its mission, the FDA requires that all products under its domain meet guidelines outlined […]
Modern laboratories in all industries are under intense pressure to reduce costs and improve operational efficiency, while at the same time enhancing quality and maintaining regulatory compliance. Additionally, the rise of R&D externalization strategies and contract research organizations (CROs) in the pharmaceutical industry has resulted in labs collecting large amounts of data from multiple partners, leading to a significant increase in laboratory workflow complexity.
Stability studies are used to assess the shelf life of a product by storing samples under controlled environmental conditions for defined lengths of time prior to testing. Stability studies may be accelerated or real time; which of these is appropriate depends on the product under test or applicable regulatory requirements.. Managing multiple studies can be complex and time consuming, however the Matrix Gemini Stability System simplifies the whole study management process. As one of the most complete and mature study management systems on the market, Matrix Gemini Stability continues to gain traction and market share. Its highly flexible graphical configuration tools make it easy to configure the system to each customer’s exact needs, while providing the flexibility for change as the customer’s requirements evolve yet at the same time maintaining the underlying stability functionality. Not only that, a new stability analytics capability has been introduced which includes a fully integrated charting module to provide early indications of shelf-life performance for each product, or batch of product, under test.
As clients go through the process of getting approval for laboratory informatics purchases, CSols experts often field questions like, “How much does a LIMS cost?” or “Is an ELN worth the investment?” or “What is the ROI for LIMS?”