Worldwide Clinical Trials employs more than 1,400 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia and Asia. One of the world’s leading, full-service contract research organizations (CROs), we partner with sponsors in the pharmaceutical and biotechnology industries to deliver fully integrated clinical development and bioanalytical services, extending from first-inhuman through phase IV studies. Grounded in medicine and science, Worldwide Clinical Trials enables sponsors to move from medical discovery into clinical development and commercialization, helping bring innovative solutions to market that deliver enhanced value and improve patient lives. Our employees are among the best in their fields – clinicians, scientists, operational and regulatory specialists who offer expertise across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune mediated inflammatory disorders (IMID), and rare diseases.
Media Fill Inspection in the pharmaceutical industry has long been based on growth media culture methods. The general approach to media fill inspection is to incubate media filled vials for 14 days and then determine potential contamination with a visual inspection of the media sample. Over the last decade a number of Rapid Microbial Methods based on various analytical techniques have been implemented. These provide quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods. Recently, it has been demonstrated that laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product.
Proven in hundreds of installations, the Model R OXIGEST® treatment system provides stable operation and flexible process options for sanitary and industrial/process wastewater applications. The OXIGEST® design encompasses complete aeration, clarification and advanced treatment in concentric tankage while allowing these unit processes to be individually separated and controlled. Its concentric tankage maximizes space efficiency in its footprint, thereby preserving precious facility land for other key plant operations.
The weighing module Novego® was specifically developed to meet the increasingly stringent requirements of the food industry. This hygienic all-in-one solution boasts a range of innovative properties to ensure simple, error-free installation and maximum resistance to lateral forces.
Water and wastewater treatment plant design is a large scale, complex engineering effort requiring a design team, often spread across many offices, and involving collaboration between different consulting firms, contractors, and owners. Bentley’s solution creates multi-discipline 3D models that can optimize project delivery and improve the management of infrastructure asset information as the project passes from design into construction and ultimately through to operations.
Designed and built to comply with FDA, GMP standards and to satisfy the demands of the pharmaceutical industry, Tablex 2 metal detectors for tablets and capsules provide the ultimate in mobile, fully integrated product inspection and rejection systems.
Parkson’s Model SRC and SRM Oil/Water Separators offer a reliable, compact, and economical solution to a wide array of oil/water separation applications. The Oil/Water Separators remove free, non-emulsified oil and settleable solids to produce an effluent with less than 10 mg/l of oil droplets 20 micron or larger.
Alchemy’s Total Operational Performance System (TOPS) is a proven process that prioritizes safety, quality, yield, and productivity objectives to optimize the operations and profitability of your organization. This is accomplished while promoting a culture that includes commitment, behavior, service, and teamwork.
KOMAL "ED" series of Electrodeionization unit employs EDI technology to produce high purity water. EDI process systems replace conventional Dl mixed bed resins unit to produce deionized water. KOMAL EDI does not require shutdowns to regenerate the resins with chemicals or replacing resins. Consistent high purity Ultrapure water having resistivity of 12-15 Mohm .cm can be produced.
CLINICAL TRANSPARENCY
Clinical trial sponsors are required by law to disclose information on their clinical trials in multiple places. These regulatory requirements continue to change as new mandated registries emerge and the scope of disclosure expands. This dynamic scenario creates a challenge for sponsors who must track and manage disclosure content that is being prepared for different registries, with different requirements.
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