There were numerous articles in September 2018 that covered a wide range of topical issues. Here are five of the best stories you might have missed… (Click the headline to finish reading the story)
There are certain trends in audits and inspections, which, regardless of the company, phase or type of clinical trial, seem to be ever-present. Some of them are indeed preventable, but require not so much a change in technology or process, but by a change in human behavior.
We have all heard of ALCOA, but what about MALCOA? The bad things that happen during an inspection or audit.
The development of new medicinal products has become increasingly expensive over the last decade. Even when costs and timelines have been properly assumed in the Clinical Development Plan, final budgets are retrospectively usually much higher, whereas timelines are often not met.
The careful selection of the “right” contract research organization (CRO), as well as specialized vendors, could play an important role in staying on track with budget and timelines.
Most clinical trial sponsors are aware of the EMA requirement to produce and distribute public clinical trial summaries. Some sponsors have begun to set up processes in which to create summaries, and many more are piloting new internal or external approaches.
While some guidelines exist and a moving deadline has offered a brief reprieve, it looks like all sponsors who conduct clinical trials with sites in Europe will be required to start submitting these summaries in 2019.1 Canada and the U.S. have also created policies that encourage public study summaries, and experts expect further regulations in the near future.
On June 23, 2016 the U.K. decided to leave the EU, a decision which comes into effect on March 29, 2019. Since the U.K. government gave the green light a year and a half ago leaders from each industry have tried to plan for every case possible; hard Brexit, soft Brexit and even a no Brexit.
With such high levels of uncertainly and lack of clarity on behalf of the government, most companies have opted for the worst possible scenario to ensure that come March 29, 2019, their supply chains do not come to a stand-still affecting their operations.
Relationships in general are complicated and require constant massaging and manipulation. Anyone in clinical research, knows that the relationship between data management and clinical operations is an important paradigm. There has however, been an ongoing struggle to establish “perfect communication” between the two areas in clinical research. And, let there be no misunderstanding, there is no such thing as “perfect communication” in this industry or in life. However, when I think about how I would ensure that the communication pathway was solid between not only DM and CO, but with other key departments as well, a few ideas come to mind.
In case you missed the Patient Centricity spotlight last month, click here to read exclusive articles delving into the current issues and concerns involving patient centricity.