A collaboration of companies was formed to provide a world-class outsourcing solution for the pharmaceutical, biotech, and medical device industries that is both cost-effective and operationally efficient.
The goal of this alliance is to leverage the strength, expertise, passion and integrity of the organizations who are part of the consortium by delivering equilateral expertise across all functional areas that comprise the R&D organization. Further, they aim to remove barriers that prevent treatments to market in a timely fashion, thereby improving patient outcomes.
To date the member companies include Clincierge, offering patient and caregiver services to help reduce barriers to clinical trial participation, enhancing enrollment, and reducing drop-outs; FMD K&L providing a range of services in data management, biostatistics, statistical programming, CDISC compliant eSubmission, and drug safety; inSeption Group providing clinical operations, project management and monitoring, compliance auditing, regulatory affairs, pharmacovigilence and drug safety, medical writing, and contracts and proposal services; One Source Regulatory specializing in regulatory and medical advertising and promotion, regulatory drug product labeling, and healthcare compliance; Pyxa with a focus on regulatory solutions, specializing in submission management, information and systems management, process development, and optimization.
By leveraging the cross-organizational expertise through flexible and innovative partnerships of companies within the consortium, they are able to drive operational efficiency and provide cost-effective solutions seamlessly to get things done right the first time.