Citeline通过监管和医学写作服务扩展生物技术的带宽

Citeline Expands Biotech’sBandwidth withRegulatory& Medical Writing Services The challenge A mid-size biotech specializing in oncology and rare diseaselacked the bandwidth, expertise, and resources to handle itsregulatory writing requirements independently and sought apartner to outsource QC and support medical writing. The client required end-to-end projectmanagement and regulatory writingsupport for timely and accurateregulatory submissions with thechallenges of no designated disclosureteam and little to no processes/systemsin place to support this function Individual team members had multipleresponsibilities and required morehands-on support tomanage theproject The team faced very tight deadlines The solution:Citeline Regulatory & MedicalWriting Services •Providing the client with senior and experienced regulatorywriters who could offer best practices for implementation•Approaching the project with an entrepreneurial mindset, workingas project managers to ensure accuracy (QC) and timeliness,taking on disclosure tasks with access to a global team•Offering a flexible arrangement so the sponsor could scaleservices up or down as needed Outcomes& Success Met project deadlines Ensured highquality and accuracy ofregulatory documents Received a dedicated lead writer to learn companyprocesses and reduce the burden on resources Formed a trusted partnership, becoming the go-toresource that can be counted on every time “Writers integrated into study teams seamlessly to producehigh-quality documents, guidance, project management,and provided support outside of the project scope.” — Senior Director Medical Writing