Our Services
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Strategic Planning, Implementation and Medical Monitoring
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Perhaps your company is developing a vascular targeting agent for solid tumors, and needs a single experienced medical monitor for the global development program. Or, as with many sponsors targeting multiple sclerosis, it may be that your firm intends to initiate trials in Eastern Europe or Asia. You need a board-certified neurologist who can design a top-quality proof-of-concept MS trial, and who also has worked with various CROs in Ukraine, Georgia, Serbia or India to help with selection of the best vendors. You've come to the right group for help.
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ECG issues? Perhaps your company has been placed on clinical hold with FDA due to a possible QT signal based on preclinical data. Inn late 2008, SPCI faced such a challenge, and our team wrote the crossover design TQT protocol, helped select the vendors and site, medical monitored the study, reviewed and cleaned the blinded data, and helped write the definitive, E14-compliant study report providing evidence of lack of effect of the candidate molecule on QTc. FDA approval to move forward was granted in March of 2009, less than 4 months later.
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SPCI consultants have been medical monitors and scientific advisors on over 500 clinical trials of products in phases I - IV, with broad experience in managing and interpreting safety data from diverse clinical studies across dozens of therapeutic areas.
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Medical Writing
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A recent SPCI client was ready to prepare and submit a BLA for their monoclonal antibody for a cancer indication, but had insufficient in-house resources to write the Clinical Summary of Safety - and company shareholders had been promised a BLA filing within 6 months. Enter SPCI, who quickly assembled a writing team consisting of a senior medical writer and 4 board-certified physicians (representing specialties from internal medicine, gastroenterology, neurology, pulmonary disease and critical care) who prepared the CSS in 8 weeks, start to finish. FDA granted fast-track approval of the product 9 months after SPCI was first contacted by the client.
SPCI has a number of experienced medical and technical writers, including PhDs, RNs and physicians skilled in the writing of protocols, clinical study reports, narratives, and summaries. SPCI staff have authored the safety sections of numerous successful regulatory submissions from INDs to NDA/BLA submissions, including NDA Special Reports on cardiac safety and potential QT effects.
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Drug Safety
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SPCI's physician and RN consultants have had responsibility for managing drug safety and pharmacovigilance for dozens of sponsors over hundreds of trials, from SAE processing to narrative preparation and medical review, to expedited reporting all the way to preparing Clinical Summaries of Safety and ISS submissions.
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While we haven't done absolutely everything - if SPCI consultants haven't done something before, we'll be the first to tell you that - the chances are that we have the relevant experience your program needs to get where you want to go.
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