Editorial Sponsored by Bristol-Myers Squibb
Bringing a medicine to market is not easy. It takes time. It takes money. It takes research. But it also takes something else that is surprisingly often overlooked—documentation. And that’s exactly why Sholeh Ehdaivand founded LMK Clinical Research Consulting (LMK).
“I had been involved in clinical research for over 15 years and I was astounded to see the number of life sciences companies that were denied regulatory approval for certain medicines and received major penalties from the regulatory agencies because they were not compliant with their documentation,” Ehdaivand explains.
“From my interactions with colleagues and friends, I learned that this was an industry-wide problem. For many firms, it’s just the last thing they think about, if they think about it at all. Often, they finish the trial and then there’s a mad scramble to pull it together,” she continues. “But today’s advanced technology is giving regulatory agencies more transparency into the actions that companies are taking or not taking. Therefore, improper documentation can actually prevent a medicine from going to market. That’s when I started to get companies to think differently about the documentation they produce and collect as a result of clinical trials.”
Headquartered in Huntersville, North Carolina, LMK employs 25 diverse documentation professionals across the U.S.
Providing “comprehensive document management solutions,” LMK creates custom and complete processes to meet the needs of the pharmaceutical and biotechnology companies and clinical trial sites.
Built on the principle that the Trial Master File (TMF) is the foundation of every clinical trial, LMK helps its clients ensure the TMF and the trial itself are in compliance with regulation.
“We have a golden rule: If it isn’t written down, it didn’t happen. Everything that occurs throughout the life of a clinical trial must have documentation to prove it actually happened and to ensure that patients rights and safety were protected. We help our clients ensure that everything is documented and verifiable when seeking regulatory approval,” Ehdaivand states.
“But there’s a genuine lack of understanding about the TMF. First, there are many components to it. So, it’s complicated. The other issue is that few life sciences companies have staff that are fully conversant in the TMF. That’s what we provide. That’s also why we created the TMF University,” she adds. TMF University is an in-house documentation certification program in response to the expertise gap she adroitly recognized.
Comprised of 18 distinct courses, it is the only documentation certification program in the life sciences industry, at present. But Ehdaivand is quick to point out that her success was not only the result of addressing a unique niche.
“As a small company, it’s sometimes very difficult to get large companies to even look at you. People think it’s risky to work with a small organization. They think, ‘You’re just 25 people. How will you support an organization of 35,000 or 40,000 people? You just don’t have the structure in place to support our needs’,” says Ehdaivand.
One large company that did notice LMK is Bristol-Myers Squibb (BMS), which has mentored Ehdaivand through the Diversity Alliance for Science. The focus of the program is to identify, develop and help increase corporate spending with certified diverse suppliers in health care, research and development. Diverse suppliers apply for a one-year mentorship with one of the corporate, academic and governmental entities in the life science and healthcare industries.
For LMK, it’s a mentorship that has yielded many benefits.
“I can’t say enough about how much Bristol-Myers Squibb (BMS) has done for us. BMS has mentored us for a year now, meeting with us once a month. They’ve really given us the tools we need to strengthen our organization, not just to grow, but to have the infrastructure in place to work with large companies. They’ve helped me ensure that we have a company culture that supports innovation and growth. And they’ve really taken the time to give us the tools we need to build the infrastructure to work with large pharmaceutical companies,” she continues. “Finally, they’ve helped us become a nimble organization with sustainable processes, so that we can respond fully to the needs of any organization. Bristol-Myers Squibb has just been incredible.”
Though Ehdaivand makes founding her business sound easy, on further inquiry, it’s clear that speaks more to her grit than an easy path.
“It takes a lot to start a company. As a woman, it takes even more as there are greater impediments. There are many things that can stop women from being successful, from traditional family commitments to getting people to take us seriously,” Ehdaivand states.
“I founded this company because I saw a very real industry need. Now, we’re a diverse, certified, woman-owned company and small business. So, it hasn’t been easy, but we provide an essential service. In the life sciences industry, any delay in getting to market can prove fatal. There is so much competition and you want to be the first company to get your medicine to market. Proper documentation is one thing that’s relatively easy to fix that can have a huge impact,” she says.
Bringing a medicine to market takes time, money and research. But it also takes proper documentation, LMK Clinical Research Consulting’s specialty.
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