August 11th, 2016 – IvyExec, Executive Insights –
The process of conducting a clinical trial can be long and grueling.
Throughout the research journey, it is essential that the trial sponsor rigorously maintains documents and content to ensure the quality and precision of the data gathered. Furthermore, regulators can require access to these documents and content at any time before, during and after the trial has been concluded. A Trial Master File (TMF) is the main set of these documents and content collated together so that all stakeholders in a trial can easily access and view them. However, even when the science involved in a trial is impressive, the TMF can make or break a new drug or device in the regulatory process.
After 15 years working in the field of clinical research, Sholeh Ehdaivand realized that there was a major opportunity to help trial sponsors manage the TMF process.
“I felt that clinical research is where I could have a real impact on people’s lives and help cure diseases,” Ehdaivand tells Ivy Exec.
Today, Ehdaivand is the principal consultant, president and CEO of LMK Clinical Research Consulting. Founded in 2013, LMK Clinical Research Consulting provides guidance and management for TMF development across a broad range of life sciences clients. She and her team help companies as big as Pfizer as well as small biotech firms navigate through the challenging process involved in creating and maintaining a TMF.
“LMK provides consulting services to our clients with specific emphasis on the vital, but oftentimes misunderstood and overlooked TMF.”
Currently, LMK Clinical Research Consulting employees a staff of over 20 people. Ehdaivand describes the company structure as being lean and flat as she wants to make sure that everyone on her team will always have access to her. Given that the company serves such a wide range of clients large and small, a nimble workforce ensures that LMK can customize their services in every scenario.
“What’s right for Pfizer is not going to be right for a small biotech firm,” Ehdaivand says. “We’re able to [customize solutions] because our employees have such diverse and rich backgrounds.”
However, extensive training on the job is a must. “The absence of knowledgeable experts in clinical documentation is problematic,” Ehdaivand explains.
To that end, she has three instructors on staff to ensure that LMK’s consultants are always kept up to date on the latest changes in a very dynamic industry. She has also developed a suite of courses for her employees to continue their learning about clinical trial documentation and educate themselves to better empower their clients.
This training has made all the difference. Setting LMK Clinical Research Consulting apart from the competition, Ehdaivand says, is this talented workforce of consultants.
“[Our competitors] rely heavily on technology without the process and the people,” Ehdaivand says. “Technology is great but cannot work in a silo. Life Science organizations need to have the trifecta working together in harmony.”
Needless to say, it also helps that Ehdaivand has years of experience and is hands-on at the helm of the company, never afraid to get in the trenches with her employees and pass her knowledge along to her clients. But Ehdaivand hopes to share more than just her industry-honed expertise with her employees. As president and CEO, Ehdaivand hopes that her passion for the industry can spread throughout her organization.
“[I wanted to] create a company where every employee is passionate about what we do and believes in what we do,” she says, noting that already she’s had one new employee seek to join LMK because he so believed in the company’s mission. “We are nothing without good people: if we don’t have good people, we don’t have a good company.”
Ehdaivand plans to engage in controlled growth, ensuring that her employees are trained on the complex process of building a TMF, citing studies showing that employees who lack training often leave their jobs.
Personally, Ehdaivand finds her daily inspiration to push her company forward in her two children—LMK is a combination of their initials.
“Being a working mom is so difficult, [you’re always] juggling a million things at once. I wanted them to have something to be proud of me,” she says. “[I also wanted] to show women who think that they can’t do it that they really can.”
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