There are several lessons that companies and investors can learn from the collapse of Theranos, and one of the key takeaways is in the area of transparency.
There are several lessons that companies and investors can learn from the collapse of Theranos and one of the key takeaways is in the area of transparency.
Theranos, which amassed a market value of about $9 billion at one point, was remarkably secretive about its research and, pretty much everything else. If investors were more demanding of transparency, perhaps the troubles the company found itself in, particularly the invalidation of more than 10,000 blood tests that brought on numerous lawsuits and the closure of its laboratories, may not have had to have happened. Calls for greater transparency in the life sciences industry have increased over the years, particularly in the areas of clinical trial research.
One area where some companies can improve transparency, both internally and externally, is to digitize documentation. One of the companies leading the charge in this direction is Utah-based MasterControl. Jon Beckstrand, chief executive officer of MasterControl, told BioSpace in an exclusive interview that taking paper documents out of the vault and digitizing them is “about getting the data out of locked doors” so it can be easily accessed.
“This can help prevent fraud by providing access to the data,” Beckstrand said. “It also helps drive efficiency throughout the organization.”
While Beckstrand is committed to promoting the ideas of transparency in documentation as a way of protecting companies and investors, he also understands the importance of creating greater efficiencies in the pharma and life science industries. Beckstrand said his company’s product is in use in the top cancer institutes in the United States. With the life-saving research being conducted there, he said it’s important for all the people who work at MasterControl that their software provide the highest and most efficient service.
“If they can get those to market faster with our quality system, they can affect hundreds of thousands of lives. We want to help get these products to market faster. People need these products,” he said.
MasterControl’s core offering places a company’s documents into a connected system. That allows companies to accelerate return on investment (ROI), as well as increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. The MasterControl cloud-based solutions provide companies with the ease of automating new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. Beckstrand said the company automates and securely manages critical business processes across its entire product. He said MasterControl puts everything into an online system and tracks all changes made to them. That way, there is a record every time a document is updated or changed by internal hands. The program can also keep changes made from outside entities, such as external auditors. Having a clear audit trail is important for a company and it’s much safer, Beckstrand said. As an example, Beckstrand said some companies rely on “locking up their data” in order to feel more secure. However, he said the problem with paper files is someone can pull out a file and put a new one in. “And there’s no audit trail,” he added.
With MasterControl, he said every document has an audit trail. Any time that document is changed, the system automatically shows what the change was and why it was made, Beckstrand said.
MasterControl was formed in 1992. It started out as a company to help manufacturing companies comply with ISO regulations. It pivoted to the life sciences industry in 2002, which has become its key focus.
With the MasterControl system being a single system, Beckstrand said it allows the company to provide clients with a much higher quality.
“It improves the efficiency in what we can offer to clients,” he said. Beckstrand added that being on a single-system also provides additional security for a company.
MasterControl has seen significant growth in recent years and Beckstrand does not see it slowing down any time soon. Over the past two years, the company has seen 100 percent growth in Europe, as well as a 50 percent growth in Asia. That growth is expected to increase, which is why the company will likely add another 300 employees this year.
