May 11, 2015, Lynn Fosse, Senior Editor, CEOCFO Magazine –
CEOCFO: Ms. Ehdaivand, what is the focus at LMK Clinical Research Consulting today?
Ms. Ehdaivand: Our focus at LMK is to operationalize the Trial Master File for the Life Sciences Industry. We are exclusively focused on Trial Master File (TMF) management and we offer comprehensive TMF services specializing in the strategic development, project management and quality control of documents and content that support the clinical development process. From study start through completion, our TMF experts deliver quality document management and TMF solutions to ensure our client’s TMF is regulatory inspection-ready at all times.
CEOCFO: Are you reviewing as the company goes along or do you review the documentation at the end point? What is the process?
Ms. Ehdaivand: Great question. We do both depending on our clients’ needs. We have established processes for ongoing periodic reviews, which occur throughout the conduct of the study, and we have another set of processes for file review at the end of the study. We established the ongoing review process to accommodate the needs of a study in start-up, maintenance and study closeout with the understanding that content is constantly being filed. The end of study review was established with the understanding that all expected content should be present in preparation for a regulatory submission (if applicable). In all, whatever our client needs, we can provide.
CEOCFO: It seems to make sense to have the documentation reviewed as you go along. Is this a newer approach?
Ms. Ehdaivand: Generally speaking, ongoing TMF reviews are a newer approach for most of our clients. It makes sense to have a proactive approach and review content as the study goes along to confirm that all content is always regulatory inspection ready. Unfortunately, too many companies either do not believe they have the resources, or they lack a document tracking process (or both!) and they do not think about the review on an ongoing basis. When the study is complete and ready for regulatory submission that is typically when the TMF becomes important and the review process commences. We can perform a review at the end of the study; however, there are risks associated with this approach. It is sometimes more difficult to obtain missing documentation or correct discrepancies retrospectively. Of course, the approach that will yield the most robust finished TMF is to review on an ongoing basis and correct discrepancies in real time (if possible).
CEOCFO: When you are reviewing what do you look at that others do not review or may tend to miss?
Ms. Ehdaivand: Our approach is different. We provide customized, expert solutions for our client. Our sole focus is on TMF operations and nothing else. We do not sell eTMF technologies, but have experience in all of the major systems. Additionally, all of our employees and consultants all have an average of 10 years experience in clinical research and document management. Working knowledge in the clinical research industry, regulatory requirements and experience with different technologies enables our staff to understand the documentation that is required for a TMF. We review our client’s SOPs (to have an understanding of their processes), study reference documents (e.g. study protocol) and the client’s TMF reference document (e.g. TMF Master Table of Contents) and customize our review of their TMF based on their needs. For example, if our client has a process whereby Case Report Forms (CRFs) are approved by the Study Manager and Data Manager, but documentation of the approvals are missing, then that is a red flag we will address. We also perform cross-document reviews ensuring that required documents (e.g. Curriculum Vitae’s for all site personnel listed on the Form FDA 1572) are present and complete. It is having a helicopter view of the study that we are looking at and then digging deep into the files that we are reviewing.
CEOCFO: Are there many companies in your space?
Ms. Ehdaivand: There are many standalone consultants, and quite a few eTMF vendors, but there are not many companies that provide TMF operational services and that is something that we pride ourselves on. There are many eTMF technologies that are out there and for our company, we work across all of them. We do not have any alliance with any one particular eTMF system. That really gives us the ability to help clients with eTMF selection, another service that we offer. We help them compare the systems that are currently available and help our client’s select the best eTMF system to meet their specific needs. When it comes to actually providing the services that go along with the eTMF, there are not many choices.
CEOCFO: How do you assess an ETMF system for a client and help them decide?
Ms. Ehdaivand: We have in depth knowledge of the major eTMF solutions currently on the market. These solutions range from intricate, highly customizable solutions with all of the so called technological “bells and whistles” to more streamlined electronic filing systems. I am impressed with array of technology available from both newer and more established companies. While impressive, these choices may also be overwhelming for our clients, so we try to advise our clients on the best solution that fits their needs and their budget. If they are a smaller company or a smaller study, they probably do not need a highly customized solution, which is ultimately incredibly pricey. They probably just need a simple electronic solution.
CEOCFO: How do you keep up?
Ms. Ehdaivand: There is an incredible amount of information to stay on top of, so to stay current, I am a member of the TMF Reference Model Group. Through this and my many years of industry experience, I have made connections with many of the eTMF executives and sales representatives. Through this, I can meet individually with them to ensure I completely understand their solution. I also regularly attend conferences, webinars and networking events to ensure we are aware of all of the newest technologies. In addition, I read all of the message boards, press releases, and follow these companies on their social media such as LinkedIn, twitter and Facebook to stay recent with their updates.
CEOCFO: How do companies find you and how do you reach out for new potential clients?
Ms. Ehdaivand: We advertise a great deal on social media such as LinkedIn, Twitter and Facebook, but 90% of our clients come from referrals. One company uses us and likes us, so they tell colleagues at another company. We also have quite a bit of repeat business; we appreciate our clients and work to create lasting relationships with all of them.
CEOCFO: When you review the documentation and errors, does the company come back to you for a final review or is it a one-stop process?
Ms. Ehdaivand: We can do either. We can do everything; review and correct, or we can review and document the deficiencies and discrepancies and provide that information to our clients and they can perform the remediations themselves. Our model is flexible. We deliver customized solutions to deliver the services our clients need.
CEOCFO: Do the regulatory agencies want to see that a company has had their documentation reviewed or is it strictly for the company’s benefit?
Ms. Ehdaivand: A TMF QC process is for everyone’s benefit. We have not seen Regulatory Agencies request the reviews unless there is a CAPA in place; the important thing is if you have a process in place it should be followed. I definitely recommend having a QC process in place. Otherwise if there is not a QC process in place and documents are just being filed blindly, then they have no idea what is in their TMF repository, what is missing and if everything is complete or not. In order for the regulatory agencies not to find any discrepancies and not to have any findings, it is definitely best practice to have a QC process in place.
CEOCFO: LMK was recently certified as a Woman Owned Business. What was the process and why was that important for you?
Ms. Ehdaivand: According to my research, we are the only TMF services company with the Woman Owned Business certification from WBENC. That puts us in this selective category with other businesses, where there is a great deal of mentorship, guidance and support for each other. The certification process was very labor and time intensive. They require a great deal of documentation and an onsite visit. However, the rigorous process is there for a critical reason. It provides the credibility that is associated with the Women’s Business Enterprise National Council. We learned a great deal from the process, which was well worth it. I believe it’s incredibly important to be plugged into an organization whose mission is fuel the economy through developing women owned businesses. We will continue to feed into their network to assist other women and their businesses as we grow.
CEOCFO: What might be different a year from now at LMK?
Ms. Ehdaivand: We have an excellent TMF Project Management program. The program is relatively new, but we are introducing it with great reception to our existing and potential clients. We would like to expand our TMF management service offering, particularly to companies with an eTMF who lack TMF services. There needs to be some human interaction–some QC processes that are in place to make sure that the documents that are filed into the eTMF are accurate and that the TMF is complete and inspection-ready at all times.
We are also looking into providing regulatory documentation services to Principal Investigators/clinical research sites. The burden of completing and retaining documentation from multiple sponsor companies for a Principal Investigator and his/her staff is becoming quite burdensome on them and it takes them away from what they truly want to do and that is patient care. We would like to take that burden off of them and let them focus on the patient care.
CEOCFO: Why choose LMK Clinical Research Consulting?
Ms. Ehdaivand: We are the only Woman-Owned Certified, TMF Services Company. We offer customizable management resources from our unique domestic and international experience in clinical research and document management. We have true TMF experts who have a background in eTMF, clinical research and document management who know and understand the TMF. We partner with our clients to understand their needs, their studies, and provide the high quality service that they need and desire. Our staff provides TMF management not just from a document perspective, but from a TMF and clinical research standpoint. That is what really sets us apart and that is why one should choose LMK.
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