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Testimonials
Mona is the right person in the field of medical research and clinical trials. She has been a tremendous help to me to make sure my site perform the clinical research more efficiently. Her knowledge and experience in the space are tremendous assets to any company and healthcare physician. I highly recommend her.
Ali N | Clinical Assistant Professor | Aug 2023
Mona was quick to develop an understanding of our clinical issues and has great intuition and suggestions on how to move forward with improvements. She also has a well-rounded understanding of the over-arching medical device regulatory environment. She can likely assist any company working from FDA & MDR compliance / approval all the way through reimbursement in the marketplace.
Jon D / CEO / Aug 2023
Mona has provided invaluable assistance in reviewing and crafting a clinical trial protocol, as well as meticulously reviewing and editing all the documents within the trial master file. Mona's contribution to our project has been nothing short of outstanding, and I cannot emphasize enough how indispensable she has been to our team. I recommend Mona and her company Apranik, wholeheartedly and without hesitation
Richard L / FDA 510k Consultant / Nov 2023
Apranik MedTech Consulting is easy to work with, strives to achieve your goals, and cares about the quality of their results. The company has acted as a valuable partner over the past year, fulfilling a range of clinical and regulatory needs for us. This work has spanned systematic literature review for clinical evidence gap analysis, manuscript writing, clinical evidence strategy, and compliance for Europe's Medical Device Regulation (MDR). Specific to MDR, Apranik MedTech Consulting improved our clinical evaluation report and developed initial revisions of our clinical development plan, and post market clinical follow up plan. I'd highly recommend talking with Mona and her team if you have a need with clinical related affairs.
Jon D / CEO / May 2024
I highly recommend Mona Maneshi as a consultant for any organization seeking expert advice on FDA submissions and clinical trial protocol development. She serves as a consultant for us, working on our FDA's Q-submission process and developing our clinical trial protocol. From the outset of our collaboration, Mona realized how impactful our project was for women’s health and took a real interest in our project. When we first engaged Mona, we were navigating complex regulatory requirements and timelines that were critical to the success of our project. Our primary need was for someone who could not only provide expert insights into the FDA process but also help us develop an efficient, well-organized pre-submission. She reviewed large amounts of historical data and our prior clinical studies and drafted an impressive draft of our pre-sub within a week. She no doubt has done these many times before. We discussed at great length possible predicate devices as well as clinical study design. Her recommendations were invaluable in forming our strategy and path forward. In addition to her technical expertise, Mona’s communication and interpersonal skills made working with her a true pleasure. She was consistently responsive, detail-oriented, and dedicated to ensuring that we had all the information we needed to make informed decisions. Her professionalism and commitment to our goals were evident throughout our time working together, and she became an essential member of our team.
Charles T / Director / Feb 2025
Carla is an exceptional Clinical Research Associate. Her meticulous attention to detail and extensive medical expertise make her an asset to both sponsors and CROs. She approaches her work with enthusiasm, optimism, and a proactive mindset.
Julie K / Director Clinical Operations | Strategic Leadership, Regulatory Compliance
Carla is a critical thinker and problem solver. With her nursing background and extensive therapeutic area background Carla is an asset to any clinical team. Her attention to detail is remarkable. There is no task that is too difficult. She is an excellent trainer for clinical sites and sets them up for success. Carla is an absolute pleasure to work with, has excellent communication skills, and has a genuine passion for her work.
Naomi is a true pleasure to have as a CRA managing study sites. Naomi's professionalism, strong attention to detail, and knowledge of FDA guidelines and regulations is superior. Naomi was hired to perform monitoring visits and perform study site audits in preparation for possible FDA audits. Both sponsors and study site personnel enjoyed working with Naomi as well. I highly recommend hiring Naomi as a CRA to monitor clinical studies.
Marla H. / Clinical Training Manager
Naomi was invaluable in her role working with Jarvik Heart, Inc. She monitored all of our clinical sites and made sure all the data that could be collected was collected and verified all data points. In addition, she interacted with staff at each site and all feedback from the centers regarding her work was positive. The highlight of our work together was managing an unannounced FDA inspection which was flawless. I was thankful to have Naomi guiding our team. Naomi is reliable, prompt, conscientious, and it was a joy to work with her.