Nothing is more significant for meeting regulatory compliance in clinical research than chemical analysis. The ability to identify and understand the composition of chemical substances used in products or manufacturing processes ensures the highest quality standards.Read more
All modern laboratory work requires a content management system for on-site analytical data storage. The superior solution for the long-term archiving of data—to meet regulatory requirements and protect intellectual research and property—is a comprehensive software system, such as OpenLab.
What is OpenLab Enterprise Content Management? The OpenLab Enterprise Content Management System is a dedicated management system of laboratory-produced data and supporting documentation. Learn more about the advantages of its continuous operational monitoring and state-of-the-art security.
OpenLab ECM: Lab Data Management Software
What is OpenLab Enterprise Content Management? The OpenLab ECM is a data archival system commonly employed by laboratory technicians. The software of this system serves as a user-friendly central repository to support quality chemical research and development. This innovative platform allows users to securely create, manage, and reuse their critical business assets with ease.
Any archived information is remotely accessible from anywhere in the world for collaboration and analysis purposes. Users can easily share developed methods and sequences and report data collected across varied workstations and analytical instruments. Using strategic management technology, this digital storage system conveniently backs up data for historical review and regulatory audits.
The Food and Drug Administration: 21 CFR Part 11 Compliance
The OpenLab ECM supports federal regulatory compliance efforts for 21 CFR Part 11. The Food and Drug Administration regulates the security of electronic documentation and recordkeeping of a pharmaceutical company’s intellectual property and quality control system.
Companies and institutions can rely on this content management to maintain trustworthy and reliable data on laboratory ingredients or products used in clinical research and organized trials. With this compliant software, users maintain archived data for FDA regulations that prove quality system validation and audit trails.
System Advantages for Analytical Laboratory Services
The OpenLab ECM provides smart data collection and storage for the lifecycle of scientific laboratory data. This electronic database protects against the unauthorized deletion or modification of documentation. Need to generate complex reports for targeted applications? By seamlessly utilizing system features, users continuously ensure the quality, accuracy, and accessibility of analytical data.
When using contract analytical laboratory services for chemical stability, storage, or method development,companies should ensure the compliance of a laboratory’s analytical instrumentation and quality control systems. Skilled staff, validated equipment, and qualified management software are the keys to ensuring compliance for research completed in this highly regulated industry. Contact Moravek to learn more about our strategic solutions and use of the OpenLab Enterprise Content Management System.
The distinctive size, shape, and physical attributes of manufactured pharmaceuticals are significant for compliance with consumer health and safety regulations. All the while, chemical purity is the most vital aspect of pharmaceutical substances and their comprehensive quality.Read more
Radiolabeled synthesis is an intricate art and in-depth science. The foundational principles of laboratory synthesis allow radiochemists to achieve multi-step reactions that help with the study of a drug’s disposition. Performing chemical synthesis on radiolabeled compounds in an early stage of a pharmaceutical development timeline provides critical insight for commercial applications.Read more
The revolutionary radiolabeling technique is an integral component of the modern drug discovery and development process. Isotopic radiolabeling facilitates the smooth development of safe and efficient life-changing medicines, bringing new pharmaceutical products to the market to reach patients faster than ever before.
In the context of this scientific technique, there is one radiolabel that researchers turn to most often: carbon-14. Carbon-14 is a radioactive isotope of carbon, an element conveniently present in all known life forms today. Here are further details regarding carbon-14: the best radiolabel for your clinical trial.
Metabolic Stability: Locating Labeling Positions
Why is carbon-14 the radiolabel of choice for human-based research studies? Scientists turn to 14C compounds for their practical synthetic routes during challenging studies. A defined labeled position is essential for acquiring critical data during pharmacokinetics or drug discovery and metabolism experiments.
Replacing naturally existing carbon atoms in molecules with their 14C isotope is simple, as researchers can choose from an array of potential radiolabeling sites to achieve metabolic stability. As a radionuclide emitting low-energy beta particles, carbon-14 can safely obtain reliable data about measured quantitative mass balance and tissue distribution during these radiotracer studies.
Slow Decay: The Preferred Length of a Half-Life
Besides the previously mentioned characteristics of 14C, carbon-14 is also the best radiolabel for your clinical trial due to its slow decay rate. Carbon-14 has a long half-life of 5,700 years. Incorporating this radioactive label into a compound for complex evaluation is a logical choice since carbon-14 decays at a constant rate.
The radioisotope is safe and effective to use for any length of extended experimentation, as 14C will not decay during the timeframe of the study. Researchers can monitor a drug’s in vivo behavior and trace its distribution throughout the body. Those using a novel radiotracing approach can customize tagged 14C compounds to the intended use of their investigational drug products.
Custom Radiolabeling Services: Radiocarbon Experimentation
Companies or research institutions needing radiocarbon for clinical trials can turn to experienced organizations. Their knowledge and state-of-the-art equipment are necessary to execute a successful synthetic strategy and handle the challenges of custom radiolabeling.
Moravek is a well-known worldwide supplier of radiolabeled compounds. Our team of expert radiochemists stands by to take on complex radiolabeling projects. We can create a quality-assured radiolabeled 14C compound that meets the custom specifications of your clinical trial. Get in touch with a proposal development coordinator on our website today.
What defines a genuine, sound scientific endeavor? As Carl Sagan recognized, “there is much more wonder in science than in pseudoscience. And in addition, to whatever measure this term has any meaning, science has the additional virtue, and it is not an inconsiderable one, of being true.”
While pseudoscience seeks confirmation to support its claims, a study of science seeks out evidence that might prove something false. Understanding this definition is essential for scientific exploration, especially in the medical field. The work scientists complete in the lab or field for research projects benefits patients beyond measure—if the wonderous findings prove effective after trials, challenges, and investigations.
Medical scientific studies branch into two career categories: clinical laboratory scientists and clinical researchers. Let’s closely examine the similarities and differences between clinical lab science vs. clinical research; here is what to know about the essential roles of thesescientific endeavors in present-day healthcare.
How Medical Science Impacts Modern Society
The medical field is fortunately not a stagnant environment. Instead, the study is ever-evolving. By way of modern technology and growing professional skillsets, patients can receive the best quality care. Ergo, medical science is integral to today’s society to positively shape patient outcomes. Clinical scientists pay meticulous attention to details to help healthcare professionals read and interpret critical data.
Similarly, clinical research sets the foundation for medical education and understanding. With advanced technology and equipment, medical laboratories are the steady backbone that enables accurate diagnosis and treatment of diseases. A clinical scientist or specialist can test and analyze samples to gain life-changing medical information; this knowledge significantly impacts the future of human health and longevity.
Detailed Analysis: The Groundwork of Treatment and Diagnosis
Besides using scientific knowledge for detailed diagnostic analysis, clinical research influences the development of medical advancements. The analyses performed by biology- or chemistry-based scientists in the lab or the field provide a means for discovering significant breakthroughs. Whether through drug discovery and development, biotechnology, or medical devices, these scientific advances can extend or save the lives of patients.
Health Science Careers: Patient-Facing vs. Laboratory Settings
When considering clinical lab science vs. clinical research healthcare roles, understand that both are inspiring and meaningful careers. However, one helps build the future of medicine, while the other helps to identify and administer its current benefits. Only together can both advance clinical knowledge and improve patient care, whether through interacting with a patient for a study, performing laboratory testing, or specially researching behind the scenes.
Clinical Laboratory Science Defined
Clinical lab science refers to the health profession of providing necessary laboratory services for disease diagnosis, monitoring, and treatment. Medical lab professionals regularly perform tests or laboratory experiments and interpret the results. These highly skilled professionals either uncover the absence or presence of a disease in a patient, or provide fundamental data for determining the best course of action or method of treatment.
The Role of Clinical Lab Scientists
Accredited and certified clinical laboratory professionals are the cornerstone of high-quality testing and reliable analysis for medical breakthroughs. Professionals must have deep knowledge of laboratory instrumentation and testing methodologies. The use of sophisticated technology and state-of-the-art lab equipment supports problem-solving, data integration, and the evaluation of new testing methods.
After completing a bachelor’s degree in clinical or medical laboratory science, many medical lab science professionals choose to work primarily in hospital, forensic, or research laboratory settings. Alongside traditional degree-related coursework, these scientists must also undergo clinical rotations to gain hands-on experience and knowledge. This clinical understanding plays a key role in providing personalized care and consulting with physicians, even if the work does not directly involve interacting with patients. The reliability and implications of laboratory results can change or save lives.
Clinical Research Defined
On the contrary, clinical research refers to the study of medical treatments or medications on human research subjects. This vital form of medical research and examination involves the extensive use of strictly controlled clinical trials. Clinical research requires voluntary human participation to evaluate the effectiveness of new or emerging treatment drugs or prevention strategies.
Clinical research is a field of study that provides healthcare professionals of varying disciplines with a crucial opportunity. These professionals can discover how newfound medicinal developments and technological advancements may offer the best medical care for current patients. While this scientific approach is similar to medical lab work, clinical research carries out different responsibilities and procedural processes in hospitals, pharmaceutical laboratories, and research institutions.
The Role of Clinical Researchers
After acquiring a bachelor’s degree in life sciences, clinical research professionals generally obtain graduate-level education and certification. Along with educational coursework, clinical researchers must undergo clinical rotations and gain laboratory experience with independent research. If directly overseeing or administering medical services to human participants, these professionals must be licensed clinical research physicians.
The typical role of clinical researchers is to design and conduct ethical scientific investigative studies that aim to improve overall health outcomes or provide answers to human medical and behavioral inquiries. Research professionals must measure outcomes to investigate the safety and efficacy of the intervention. For this reason, they must also ensure the standardization of drugs, doses, and potency to receive reliable results throughout the lengthy and careful trial process.
The Delicate and Beneficial Science of Radiolabeling
Radiochemistry is a concrete scientific endeavor of theoretical and experimental work. Similar to any branch of lab-based science, its applications are ever-evolving for medical professions. This scientific discipline studies the chemical characteristics and radioactive properties of elements to support varying industry needs in the medical field. Radiochemists apply the advantageous uses of radioactive materials with innovative techniques, including the radiolabeling of active pharmaceutical ingredients.
For dedicated explorers of the medical world, custom API radiolabeling is a scientific technique supporting the completion of pharmaceutical research. Clinical radiolabel studies help provide a greater understanding of the absorption, distribution, and metabolism of drugs in humans.
Quality Matters: Moravek Quality Services
Professionals in this area of expertise must have a thorough understanding of good clinical practices and quality systems for manufacturing cGMP APIs. Experienced radiochemistry specialists can complete the appropriate scope of work to meet the clinical requirements of specific medical studies or research team projects.
Companies or research institutions searching for radiolabeled compounds suppliers can contact Moravek for quality solutions. Moravek is a trusted contract organization dedicated to the ongoing advancement of human health. Our QC laboratory team fully supportsmedical research and clinical trials completed around the globe.Get in touch today to gain support and facilitate successful clinical research.
Nothing is more significant to the advancement of human health than the use of safe, efficient, and innovative medicinal products. In the pharmaceutical industry, the production of these products requires adhering to current Good Manufacturing Practices (cGMP).
What are current Good Manufacturing Practices? Uncover critical information about these regulations by the U.S. Federal Drug Administration for guiding quality processes in the research, development, and production of pharmaceuticals.
Current Good Manufacturing Practices Defined
What are current Good Manufacturing Practices? Essentially, cGMP refers to the most current version of Good Manufacturing Practice regulations required by the Federal Food, Drug, and Cosmetic Act. These regulations are the foundation of pharmaceutical quality, ensuring that medicinal products are safe, pure, and effective for human use. Professionals in the pharmaceutical industry must be knowledgeable about the latest regulations as GMP standards invariably improve over time.
Why Does cGMP Matter?
The goal of cGMP is to comprehensively enhance product quality through specific design, maintenance, and monitoring processes in facilities. Quality matters, meaning these regulatory standards carry tremendous weight in quality control and assurance. Developers, manufacturers, and packagers of these drug products must ensure that the identity, quality, purity, and strength are of the highest possible standard.
cGMP is of great importance for those taking OTC drugs, biopharmaceuticals, or prescribed drugs by healthcare providers. Through these meticulous regulations, the FDA can verify that a pharmaceutical is well-tested, labeled correctly, viable for use, safe for human consumption, of the right strength, and not contaminated.
Ensuring Compliance With cGMP Regulations
How do cGMP regulations apply in facilities or laboratories? To comply with these practices, companies must implement and maintain quality management systems, reliably use good quality raw materials, set up straightforward operating processes, and regularly test for any deviations from standard quality. Professional organizations must utilize well-maintained facilities and equipment, employ those properly qualified and trained, and sustain cGMP processes that produce reliable and reproducible results.
Those cGMP-certified have additional credibility to assure their facilities are scientifically sound and quality operating procedures are up to date. Moravek is an experienced contract manufacturing company offering solutions for medical research and clinical trials worldwide. Learn more about our cGMP Quality System, dedicated QC lab, and custom API pharmaceutical manufacturing services on our website.
The rapidly evolving field of analytical science continues to expand with state-of-the-art technology, sophisticated equipment, and chemical innovations. Our modern life sciences would be impossible without analytical science. The analysis of chemicals in professional laboratories plays a pivotal role in safeguarding quality and maintaining public health and safety.
What is an analytical and quality laboratory? Let’s closely examine how a dedicated lab serves the unique analytical needs of the scientific community with expert technical precision.
The Foundation of Analytical Testing
What is a specialty analytical and quality laboratory? A QC-driven laboratory serves as the steady foundation of analytical chemistry. Analytical testing—known as materials testing—involves using skilled techniques to identify the characteristics of a chemical sample. Common applications include the assurance of safety and quality of food, water, and pharmaceuticals, alongside the provision of precise measurements and documentation.
The analytical work completed in a QC laboratory is essential for legal trade and commerce. Thorough laboratory composition testing and measuring can confirm chemical stability, assure proper method feasibility and structural development, and identify potential product inadequacies or contaminants.
How Laboratory Precision Ensures Quality
The use of analytical techniques and instrumentation devices can be challenging. In a QC laboratory committed to analytical results, quality refers to the degree of compliance that meets the regulatory requirements of the customers and industry standards.
When partnering with a laboratory, a research group or organization needs to provide specific information regarding the type of materials and their properties for analysis. Then, specialists can use their knowledge to solve difficult analytical problems.
Specialty Sciences: Solving Complex Challenges
A wide array of challenges faced in society require the advanced precision of analytical sciences. Clinical research and drug development is one challenge that needs collaborative support from a world-class specialty laboratory.
Identifying precise methodologies and technical procedures is key to acquiring optimal results. Achieving the same analytical accuracy and precision across laboratory systems provides assurance of quality and safety to aid in the progress of a critical study or research project.
cGMP Quality Control: Moravek’s Expert Systems and Support
Moravek is a trusted provider of cGMP analytical laboratory services completed in our dedicated QC laboratory. With extensive experience in handling radiochemicals, our team of highly skilled staff operates QC-qualified equipment and systems to support the studies of our clients. Learn more about the focus areas and applications of our quality solutions for your project today.
As Albert Einstein recognized, “The formulation of a problem is often more essential than its solution, which may be merely a matter of mathematical or experimental skill.” At the core, chemistry is about more than discovery—the science and art of matter involve both creation and destruction. Chemistry is a scientific study that plays a pivotal role in our understanding of synthetic and physical phenomena and, as follows, both the material and natural world.Read more
The custom synthesis of chemicals provides the unique opportunity to access chemical products with exclusive characteristics. Using these services ensures a developed chemical meets the specifications required for the demands of a project.Read more