Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation. A value-added supplier management program should also consider items such as supplier capability, capacity, and contingency planning.
The data gathered at investigative sites during clinical trials is the backbone of the pharmaceutical and medical device development process. Without it, assessing the efficacy and safety of therapies would simply be impossible. Whether they are linked to a medical practice, part of an academic medical center (AMC), or operate independently, investigative sites are an important resource.
According to a common refrain, blockchain will “transform” and “disrupt” the life sciences industry. While the technology’s applications in industries such as banking and broader financial services are readily apparent and, in fact, already being adopted, tangible applications in the life sciences prove more nebulous.
The new year is just around the corner, signaling a fresh start and new beginning. Janus, the Roman god of new beginnings and namesake of the month of January, likely inspired our familiar tradition of reflection and resolution this time of year. Janus had two faces, which allowed him to look backward to the past and forward to the future.
Consultants play a significant role in the pharmaceutical, biopharmaceutical, vaccine, and medical device industries. They are experienced resources in crisis situations; when new facilities are being installed; under circumstances requiring technical expertise; and during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants, and both contribute to them.
Clinical laboratory services are the most outsourced services by pharmaceutical, biopharmaceutical, and medical device companies. Trending in the central or core laboratory services market is consolidation and integration of services through acquisitions and collaborations inorganically to expand beyond core services. Through horizontal integration suppliers increase their market share.
There is a trend within the pharmaceutical, biopharmaceutical, medical device, and vaccine industries to hire more consultants, leading to a staffing ratio that can be up to 50 percent consultants to staff for small to large capital projects.
Probably the biggest concern for anyone implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focused on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.