The process of ensuring clinical trial records are accurate
and fully reconciled between laboratory and clinical data sources can be a
point of frustration for today’s pharmaceutical and biotechnology companies.
Whether the data is coming from a contract research organization (CRO), a
central laboratory or third-party laboratories, the need for timely
availability of clean data based on unique sponsor format/industry requirements
has become extremely complex.
“As the complexity of today’s studies grow, sponsors are
often working with a greater number of laboratories in their studies,”
explained Richard Cesarski, SVP, Patient Solutions, Safety and Data Sciences. “While
these labs are specialists in sample management and generating results, their
standard report formats may not be aligned to individual sponsor requirements.”
Recognizing this gap between sponsors, their clinical
partners and the labs, Covance has launched Laboratory Data Management FSPx
(Lab FSPx), a new solution within its Functional Service Provider (FSPx)
Residues of plant protection products (PPPs) are inevitably present in or on food, even when they are applied in line with good agricultural practice. The upper limit of residue permitted on food or feed is the ‘maximum residue level’ (MRL), which, in Europe, is legislated by the European Commission based on scientific advice from the (EFSA).
MRLs are measured via crop residue field trials, which replicate the real-life agricultural conditions under which a PPP would be used. It sounds a simple enough procedure, but what studies are commonly used and what are the secrets to success?
When a patient reads the label on their medicine bottle, he or she naturally relies on the medicine to contain the correct drug, be safe, work as intended and list the correct dosage. The pharmaceutical companies that produce these medicines similarly must rely on their internal manufacturing processes and quality control testing to generate the medicine responsible for this patient trust.
For the development of biologic medicines, the process of generating a quality product is less straightforward than that of a small-molecule medicine, like pain relievers such as aspirin. Selecting the right partner, such as Covance and its ‘Central GMP Testing Laboratory’ model, can smooth the path to validation and consistent manufacturing quality for your biologic. Continue reading