Services






			Clinical Consulting Clinical/ Medical Writing Regulatory Due Diligence Private Equity Consulting Medical Films/ Video Medical Meetings/Advisory Boards Clinical Consulting: Drug Development Strategy & Study Design Consulting Clinical/ Medical Writing: • Protocol Writing Detailing study objectives, design, methodology, and statistical methods in CTD format. • Phase I Clinical Study Report Developed in accordance with ICH E3 guideline for first stage testing in human subjects, “Close-out” study reports, safety reports, etc. • Phase II/ III Clinical Study Report Full CTD-format clinical efficacy & safety report • Common Technical Document • Quality Pharmaceutical Documentation • Safety Summaries • Toxicology Studies • Efficacy • Clinical Studies TOP Regulatory: • INDs, NDAs • 510k, PMAs • Meeting Requests & Briefing Packages • Foreign Regulatory Filings • Abstracts • Posters • Publications • Literature Reviews • “White Papers” TOP Due Diligence: • We can add in-depth expertise to expand your team “just in time” for a project, or to relieve resource crunches. • These experts will review and evaluate data, interview personnel, etc., on-site domestically or internationally, or through web portals. • The team will provide a written report, along with analysis of what risks and opportuni- ties exist for the product as well as regulatory considerations associated with each segment of the product (s) or of the Company under review. • Experts available in: Regulatory Affairs, Manufacturing, Quality Assurance/Compliance, Clinical Trials (by specialty), Reimbursement, and Commercial Sales and Marketing. • Regulatory Risk and Pathway We suggest ways that could minimize regulatory problems and keep product develop- ment both cost and time efficient, finding the best possible path to a timely approval. • Estimate Development Costs We can project the cost of development for a product from wherever you may start to approval, to allow for a realistic plan. TOP Private Equity Consulting: With over 20 years in business start-up and management experience we can help you make the right decisions to get your business moving in the right direction in terms of evaluating funding possibilities and the right “match” for healthcare private equity firms. TOP Medical Films/ Video: SixDay Productions, LLC SixDay is a New York based film/ video production company specializing in meeting the regulatory and development demands of the clinical research industry. SixDay can support your project with a variety of media formats and skill sets, from videography of investigator and investor meetings, to scripted Standard and High Definition Video presentations of medical procedures, in 16 and 35mm Film; in addition, Digital Still Photography of products and processes is available. TOP Medical Meetings/Advisory Boards: Malvern Consulting Group has extensive experience with organizing Medical Meetings (Medical/Scientific Committees, Investigator Meetings, etc). We provide cost effective, professional services for our clients and their clinical associates. The following list illustrates the services we offer: • Venue selection • Negotiate contracts for venues, rooms, equipment, transportation, etc. • Plan hospitality needs • Organize all food and beverage for meals, breaks and receptions • Travel arrangements • Establish and monitor audio/video plan • On-site liaison with venue's conference services manager • Manage all on-site equipment and logistics • Receive and organize shipped materials • Setup and staff registration/welcome desk • Setup and maintain meeting rooms and event areas • Facilitate arrivals/departures • Review billing daily • Coordinate return shipping • Comprehensive invoice reconciliation and evaluation • Conduct post-event feedback and evaluations • Provide event/meeting attendee data file • Distribute thank you correspondence to all attendees Our clients can trust us with their Medical Meetings so they have the time to focus on other essentials of their clinical trial programs. TOP