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Solving the Challenges to Clinical Trial Research in an Uncertain Economy

2023年1月10日

全球流行病, 在早期阶段, 给企业带来了冰雹般的挑战, 包括进行临床试验的业务. While our 趣赢平台 colleagues have successfully conquered those challenges for our clients, new obstacles triggered by a pandemic-inflicted economy are threatening clinical trial research today. 初始资金, staff shortages and supply chain disruptions are among the factors compromising clinical trial progress and the advancement of new therapies.

小型生物技术和制药公司, 他们的资源更有限, are especially feeling the pain of impeded clinical trial research. With finite monies, funding clinical trials or attracting investors is especially challenging. Helping sponsors address lack of funding and other hurdles is where working with a trusted contract research organization (CRO) with experience and a reputation for problem solving can make all the difference.

缓解投资者的紧张情绪

Today’s investors are especially nervous about putting their money into projects with unpredictable outcomes. Heightening awareness of a sponsor’s drug or therapy and the potential to treat or cure a disease is critical to attracting investors. 趣赢平台 can 1) provide data analyses from early clinical testing for presentation to investors when raising money for later phase trials, 2)帮助准备科学会议的报告, and 3) develop a data-rich manuscript on the drug safety and efficacy for submission to a scientific journal. 如果发表, the journal article not only brings attention to the drug but also strengthens the sponsor’s ability to share its potential to investors.

消除人员配置挑战

Today’s labor shortages are a residual effect of the pandemic and seem intractable. They present yet another hurdle affecting both sponsors and clinical research 网站. Vaccine developments prompted a hot labor market for clinical research professionals, 导致工作人员从现场转移到前线. 因此, clinical 网站 faced a revolving door of new and less experienced professionals, who must be trained to implement new protocols and conduct FDA-compliant studies.

趣赢平台’s comprehensive trainings for site staff tackle this issue. 它们涵盖了监视数据和源文档, 协议的细节, and patient confidentiality while providing overviews of data management, 监管要求, 以及相关系统.

对于那些被迫裁员的公司, 或者人手有限,无法支持多项研究, we can provide critically needed expertise as well as professionals, 包括临床研究助理, 数据管理员, 或统计学家, 在需要的地方提供技能和经验.

管理资源缺口和供应链中断

 Inadequate staffing is also affecting other key collaborators essential to clinical trial research such as vendors. 例如, because competing studies and limited staffing can lead to a delay in receiving test results from laboratories, our project managers carefully plan for sample collection and testing with the team and follow up with 网站 and laboratories to ensure shipments, 处理, 报告也得到了有效管理.

Supply chain delays can hamper delivery of trial supplies and halt clinical trial 招生. 为了降低这种风险, we work closely with the 网站 and drug/laboratory kit suppliers to keep abreast of lead times, 库存, 招生, 和到期,以确保供应短缺得到缓解. Maintaining detailed tracking reports helps identify potential problems, 因此,这些问题可以在入学目标受到影响之前得到解决. 在整个研究过程中, 与经理进行开诚布公的沟通, 网站, and vendors is key to ensuring the clinical trial progresses smoothly.

推进创新疗法是我们的目标

Today’s economic climate has intensified the challenges facing the clinical trials industry. 由生物统计学家组成的专门的CRO团队, 临床研究助理, 数据管理员, 监管协会, and study managers stand ready to help sponsors overcome those challenges. 我们的创新解决方案支持成本效益的交付, 富有成效的, 以及非常成功的临床试验项目. 我们相信,只要有合适的合作伙伴, small biotech and pharmaceutical companies can thrive in this environment and bring their innovative drugs and therapies to market successfully.

克里斯汀·安德森贡献, 博士学位, 和詹妮弗·布莱恩特, MPA, CCRP, 都是韦斯特的临床试验区.

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