SPRIM PRO Announces a Novel and Validated Approach for Monitoring Infant Growth from Home in Clinical Trials, Reducing Burdens on Caregivers and Clinical Sites
September 24, 2024, SPRIM PRO – SPRIM PRO, a CRO renowned for its innovative approach to clinical trials and healthcare, is excited to announce its accepted, peer reviewed publication in Frontiers in Pediatrics medical journal entitled, “Assessment of the reliability of at-home caregiver-collected anthropometric measurements”. The publication further establishes SPRIM PRO as an innovator in the decentralization of clinical trials and the optimization of clinical trial outcomes.
BOSTON, and INDIAN HARBOUR, Fla., Sept. 24, 2024 /PRNewswire-PRWeb/ — In light of recent shortages of infant formula in the USA and an increase in FDA regulations in this sector, there is an increased need to conduct clinical trials to determine whether new formulations are safe and tolerable for infants. Historically, these trials were designed for caregivers and their newborn infants to attend 6 to 7 study visits at a clinical site for research staff to measure the infant’s growth while in these trials. This burdensome approach has resulted in many caregivers dropping out of these types of clinical trials followed by significant delays in getting trials completed.
Results from SPRIM PRO’s latest publication in Frontiers in Pediatrics support telehealth- guided caregivers’ capacity to accurately measure infant growth compared to pediatric health care professionals and highlights the importance of standardized training. “We are thrilled to be able to provide objective data demonstrating a methodology in which caregivers can reliably and accurately collect their infant’s anthropometric measurements from their home. Adoption of this approach can improve the accessibility of clinical trials and lead to inclusion of a more diverse study population,” said Dr. Jenny Ly, Director of Clinical Science at SPRIM PRO.
SPRIM PRO’s decentralized methodology solves a long-standing problem in the study of infant formula safety and tolerability. This validated methodology reduces the burden on clinical site staff, caregivers and their newborn infants by eliminating the need for time-consuming trips to clinical sites. An added benefit of this approach is that it eliminates the risk of exposing healthy newborns to viruses and bacteria commonly present in clinical care facilities and empowers caregivers to take on a key role in data collection.
SPRIM PRO’s approach enables infant formula companies to use innovation to safely, effectively, and rapidly bring their formulas to market. “We are very excited about the science, rigor, and innovation that we are implementing to bring certainty to our clients on the performance of their formulas and to astutely guard the safety of infants on par with or better than a clinical site through the use of a remote approach,” stated Dr Susan Dallabrida, CEO, SPRIM PRO.
To view and/or download the publication please visit Frontiers in Pediatrics.
About SPRIM PRO: SPRIM PRO is a scientifically-powered global boutique CRO with custom solutions that are designed to accommodate all types of clinical trials, traditional site-based and decentralized studies. SPRIM PRO also provides multi-faceted solutions for patient support programs and medical marketing and engagement. SPRIM PRO provides clinical trial and consumer health solutions for biopharmaceutical, biotechnology, medical device/digital therapeutic, infant nutrition, and consumer health industries.
Media Contact
Matt Dixon, SPRIM PRO
1 8628819904
matt.dixon@sprim.net
https://sprimpro.com
SOURCE SPRIM PRO