Sales-Link last month launched its Lab to Life Series that showcases our clients and their expertise. Today, we continue by spotlighting Max Neeman International and how they are helping pharma/biotech worldwide with medical writing services. I had the pleasure of interviewing Dr. Gunjan Agarwal and Priyanka Bhattacharya, both members of Max Neeman’s medical writing team.
Part of your success depends on documenting your research plans and results, and doing so in a timely manner no matter how many times the scope or milestones change. Whatever these requirements are, it is of utmost importance to deliver high quality written reports, submissions, and publications at the appropriate time for the benefit of your product and those potential recipients, i.e., potential investors, collaborators, FDA, Key Opinion Leaders, industry representatives and the public for educational purposes.
Max Neeman International stands ready with its full time highly educated medical writing team supported by a team of statisticians to help you ensure this happens. The India-based CRO writing team is led by a very personable, focused leader, Dr. Gunjan Agarwal. Dr. Gunjan is backed by Priyanka Bhattacharya, an experienced writer, highly educated in the US (Duke University) and India where she earned her scientific degree credentials and experience in scientific and clinical research for many therapeutic areas. They are backed by a team of scientific writers & Bio-statisticians with PhD level degrees. The team consists of generalists, microbiologists, regulatory experts, and editors. No matter the molecule, there are medical writing specialists available from within Max Neeman that has access to scientific key opinion leaders from Parent Company, Max India Limited.
The credentials of the writer is one of the major drivers to ensure proper representation of your company but this strength could not be fully realized without a starting point, a Plan, specifically a Medical Writing Plan to guide you and your research team, through the finish line.
The Medical Writing Plan should be managed by an expert that has understanding and empathy in its repertoire; understanding as to the importance to keep you on track with the plan and to routinely have joint reviews, and to have empathy for you and your busy schedule. The show must go on and that is in spite of your busy schedule and inaccessibility. A great advisor will understand your schedule and will see past the causes for delays and ensure all stays on schedule. Today, it seems everyone is on overload with tremendous workloads so technology, video conferencing and flexible scheduling are necessary and achievable with Max Neeman’s Writing Team.
The starting point for Max Neeman is to engage with you when your preclinical data is starting to form conclusions and a decision is made that you are heading to the clinic. This is a great starting point for Max Neeman to discuss your clinical development plan, investigator brochures, manuscripts, publications, regulatory submissions, and protocols. Other key writing needs are for licensing maintenance documents, labeling, patient narratives, DSMB updates, and educational documents especially for devices, where more educational training materials are crucial.
The medical writing services are compatible with ICH guidelines and similar regulatory requirements.
During my interview with Dr. Gunjan Agarwal and Priyanka Bhattacharya, they said “It is really essential to have a writing plan and calendar to coincide with your drug/device development plan. Most companies are so busy and involved in the science that the writing about the product is not always at the top of their mind, especially small to midsize companies run by high focused scientific experts, not necessarily familiar with business papers and importance of timing for filing these papers. Many miss potential opportunities where the written material will really help promote their work.” Many wait to the end to publicize their companies for market potential but there are plenty of other viable reasons to be writing at appropriate times including making materials available for investors.
When asking one of the team members what is her favorite type of writing to do, she replied that while regulatory writing is straight forward, it is manuscript/promotional writing that she finds most interesting because she gets the opportunity to describe the product from her point of view while keeping the technical content. This energy and interest in medical writing can be found throughout the medical writing team of Max Neeman International.
Max Neeman International is a full service contract research organization offering solutions to the clinical life cycle from Phases I to IV. Max Neeman International is a 100% subsidiary of Max India Limited founded in 2001 with headquarters in New Delhi, India and is a premiere Indian contract research organization with presence across the US, Europe and Asia Pacific regions. The group offers a customized platform for your drug development program through a well crafted project management solution and also extends insights towards future commercialization.