Turn to Covance FSPx® to jump-start or re-start your clinical trial
Covid-19大流行对临床开发产生了深远的影响，暂停或延迟了数百种临床试验。旅行限制和对病毒潜在暴露的恐惧阻止了许多患者进行现场访问，以及健康危机应变资源的卫生危机的程度。因此，在许多试验中暂停了入学，许多其他人在规划阶段停滞不前。[1]
We don’t know how long the pandemic will upend normal life, nor how long it will be before clinical development resumes in full swing. It’s clear, though, that for the time being, sponsors and Contract Research Organizations (CROs) must contend with a backlog of trials and find innovative ways to reduce risks for patients. Thus, the trend of making trials more patient-centric, which was underway long before the pandemic, has accelerated, and decentralized trial designs are being widely adopted, reducing the number of site visits required of patients.
Coping with external data sources
这一切都是好事，但它确实为赞助商带来了新的挑战 - 特别是在数据收集，聚合和管理周围。在分散的试验中，数据从案例报告表格（CRF）以外的来源快速流动，以包括各种类型的实验室（中央，本地，专业）以及患者报告的结果（Pro）仪器和可穿戴设备的智能手机和智能手表到贴片和孔眼监视器。越来越多的供应商以不同格式提供数据，并且所有的所有厂商都需要映射到标准，控制质量，并协调 - 所有在保持盲人的同时。
The Tufts eClinical Solutions Data Strategies and Transformation Study published in 2019 found, not surprisingly, that the increased volume and diversity of data sources being used in clinical trials is contributing to delays in trial completion. Since the last study completed in 2017, large pharmaceutical companies have reported a 32 percent increase in time from the Last Patient, Last Visit (LPLV) to Database Lock. Meanwhile, those that have implemented a formal data strategy have seen a six-day improvement from the LPLV to Database Lock, compared to companies with no formal strategy.
Recognizing the value of a data strategy especially as trials decentralize and need to make up for lost time, we’re offering a webinar, “Managing External Data Sources in Clinical Trials: Current and Future Strategies.” We’ll explain techniques for managing data from non-CRF sources and will offer advice on how to ensure data currency and accuracy and how to interface with more and more varied data sources. The webinar isopen to registrationnow.
Preparing study submission deliverables
After you’ve overcome the hurdle of Database Lock, the real work for project managers, medical coders, statistical programmers, CDISC specialists, biostatisticians, and medical writers begins: preparing the data for eSubmission to regulators.
大多数赞助商都是熟悉的with the staffing services offered by Functional Service Providers (FSPs) (see below), but may not realize that the right FSP partner is capable of actually performing the work itselfthrough a deliverables-based FSP engagement. Partnership models run the gamut from[PHP1]hiring insourced, Full-Time Equivalent (FTE) employees to relying on embedded FTEs whose work is overseen by the FSP to the contracting for unit deliverables (specific deliverables) from the FSP.
One mid-sized pharma company chose to work with the Covance FSPx® team to deliver the integrated summary of safety (ISS) and the integrated summary of efficiency (ISE), both integral to study submissions for New Drug Applications (NDAs). The challenge was to support data conversations across multiple study data tabulation methods (SDTMs) as well as perform validations and prepare reports for submission for 52 studies.Read about Covance’s approach，其中包括从52项研究的大约3,500种可交付成果转化为统一的提交就绪摘要文件。
Scaling up during the pandemic
The need to scale your workforce rapidly is challenging in the best of times, but it presents a Herculean task in the midst of the COVID-19 outbreak. One drug sponsor estimated that it would need at least a year to recruit, interview, and onboard 60 CRAs to support a study in Chinaif they did it themselves.Learn how the FSPx team stepped in to find qualified candidates ahead of schedule, even while working remotely during the pandemic.
At virtually every stage of the development process, resourcing can be tight as deadlines loom. And with timelines and work processes having been altered by the pandemic, the crunch can be even greater. FSP partners such as Covance FSPx can be a solution to meeting your business demands, whether by helping you staff up quickly, or by stepping in with our expertise to actually complete assignments.
Learn more at www.wfliji.com/FSPx
[1]De Martini, A., Lockhead, D., Plappert, L., Rountree, E., “The impact of COVID-19 on clinical trials,” PMLive, June 30, 2020.
[PHP1]如果白皮书已准备就绪，您可以在此链接到它。
[PHP2]Link to the white paper if it is ready. If not, delete this whole sentence.
