Supply Chain Integrity Featured Articles

11. CROs Can Be Indispensable As Pharma Companies Focus On Value 9/15/2016

    The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.

12. Phase I Clinical Supply Landscape: Trends, Demarcation And Security 8/30/2016

    The core addressable early phase market is USD 11.9 billion growing with a CAGR of 2 – 3 percent. Early-phase trials are outsourced at greater than 60 percent by pharma, as the trials are costly and small in number. The supply market for early phase is comprised by CROs, research centers, and academic institutes. The market size that is comprised by the CROs is estimated to be around USD 8 billion, which is about 67 percent of the early phase market.

13. Overcome The Increasing Complexity Of Clinical Logistics 8/24/2016

    Clinical trials have become more complex than ever. Although there is still some debate around exactly how complex they have become, trials today seem to have more endpoints, procedures, eligibility criteria, protocol amendments, and investigator sites than just 10 years ago. Add adaptive trials to the mix, and clinical supply executives have more to worry about than ever before. Perhaps it’s time to make your clinical supply chain as flexible as your trials.

14. Clinical Trials: A Winning Step Toward Medical Breakthroughs 7/25/2016

    There is a direct correlation between innovations in modern medicine and clinical trials. Researchers and their sponsors continue to push what is possible with new forms of life-saving therapies enabled through cutting-edge science and good, old-fashioned trial and error. Modern medicines improve quality of lives. Clinical trials improve the quality of modern medicines.

15. Clinical News Roundup: Should You Be Concerned About For-Profit Review Boards? 7/8/2016

    Clinical News Roundup for the week of July 4, 2016 featuring for-profit institutional review boards, inefficiencies in clinical trials, smarter approaches to oncology trial design, clinical trial logistics, and integration between ClinicalTrials.gov and Drugs@FDA.

16. New Coordination Hub And Distribution Center Serves Pharma's Clinical Supply Needs 4/11/2016

    In clinical trials, many functions have to operate smoothly and efficiently for an approval to be granted. With all of the attention being paid to patients, data, innovation, and new technologies, one aspect that can get overlooked is the packaging, labeling, and distribution of clinical supplies. No trial can take place unless sites – and ultimately patients – receive their required clinical supplies.

17. As Chiltern Acquires Theorem, Study Continuity Remains The Central Priority 8/7/2015

    Global CRO Chiltern has announced it will acquire Theorem Clinical Research, another global contract research firm. The company has signed a purchase agreement for the acquisition. According to Chiltern CEO Jim Esinhart, the move was made in response to client demand for a CRO partner that could provide scientific and operating strengths across the globe, but do so in a responsive and flexible way. The acquisition will bring together 3,700 employees of the two CROs working in more than 45 countries. The combined company will adhere to a stated philosophy of clinical trials “Designed Around you.”

18. Should You Outsource Your Pharma Supply Chain? 6/11/2015

    Have you thought about taking the bold step of outsourcing some or all of your pharma supply chain? If so, you won’t be the first company to consider it. But is outsourcing the best option?

19. Implementing A Vendor Oversight Quality Management System: Insights From Biogen Idec Data Management 11/21/2014

    As the volume and complexity of outsourcing increases, it becomes important to implement a risk-based approach to vendor oversight. Regulatory agencies expect that sponsor companies will ensure qualified personnel are working on their behalf, following GCP-compliant processes and have adequate controls in place to ensure patient safety and data integrity.

    Unfortunately, it is also common for silos to exist in many large organizations. Much of what the data management area might do is contained within that department. What the clinical operations department does might be confined to clinical operations. As a result, not all information generated on vendor interactions will be passed through all of the functional areas requiring access to the information.

    When those regulatory inspectors do show up at your door, it is not uncommon for them to ask “what have you done to oversee this vendor?” or “what evidence of vendor oversight can you produce?” As the sponsor is ultimately accountable for the quality of the data and the study conduct, it is important to ensure that oversight is applied throughout the lifecycle of the study. At the same time, it is important to not duplicate effort, micromanage the vendor, or fix issues that should be resolved by the vendor.  Oversight is essential, but spending time on unnecessary activities can have the effect of decreasing quality.

20. Reducing Clinical Costs With The Right Drug Distribution Strategy 11/21/2014

    Can having the right drug distribution strategy help to significantly reduce the cost of clinical trials? A study conducted by eClipseCRO has shown that it can, with quite impressive results. The study, released earlier this year, was designed to provide a comparative analysis between two identical Phase 3 studies, each with a total enrollment of 300 patients. According to Leslie Bihari, president and CEO of eClipseCRO, both studies were conducted with identical study designs, drug administration schedules, clinical technologies, and sites. The only variation in the studies was due to persistence of the disease condition (chronic versus acute) and the strategy used for the packaging and delivery of the drugs.

    “One of our goals in comparing the two studies was to figure out a way to bring down the overall cost,” says Bihari. “But at the same time we saw the opportunity to use technology to also improve both product quality and patient safety. Those were the critical factors on which we focused.”