解决不确定经济环境下临床试验研究的挑战

The global pandemic, in its early stages, brought a hailstorm of challenges to businesses, including the business of conducting clinical trials. 而我们趣赢平台的同事已经成功地为我们的客户克服了这些挑战, 如今，由流行病造成的经济引发的新障碍正威胁着临床试验研究. Initial funding, 人员短缺和供应链中断是影响临床试验进展和新疗法进步的因素之一.

Small biotech and pharmaceutical companies, with their more limited resources, 是否特别感受到临床试验研究受阻的痛苦. 由于资金有限，资助临床试验或吸引投资者尤其具有挑战性. 帮助赞助者解决资金不足和其他障碍的地方，是与具有解决问题经验和声誉的值得信赖的合同研究组织(CRO)合作的地方.

Easing Investors’ Jitters

如今的投资者对于把钱投到结果不可预测的项目尤其紧张. 提高对保荐人的药物或疗法以及治疗或治愈疾病潜力的认识，对吸引投资者至关重要. 趣赢平台可以1)提供早期临床试验的数据分析，以便在为后期试验筹集资金时向投资者展示, 2) help prepare presentations for scientific meetings, 3)编写一份关于药物安全性和有效性的数据丰富的手稿，提交给科学期刊. If published, 这篇期刊文章不仅引起了人们对药物的关注，而且加强了赞助商向投资者分享其潜力的能力.

Eliminating Staffing Challenges

今天的劳动力短缺是疫情的残余影响，似乎难以解决. 它们是影响资助者和临床研究地点的又一个障碍. 疫苗的发展促进了临床研究专业人员的热门劳动力市场, resulting in a shift of staff from sites to the front line. Thus, 临床站点面临着新入和经验不足的专业人员的旋转门, 谁必须接受培训以实施新方案并进行符合fda要求的研究.

趣赢平台对现场员工的全面培训解决了这个问题. They cover monitoring data and source documentation, protocol specifics, 在提供数据管理概述的同时，为患者保密, regulatory requirements, and associated systems.

For companies forced to trim staff, or that have limited staff to support multiple studies, 我们可以提供急需的专业知识和专业人员, including clinical research associates (CRAs), data managers, or statisticians, to offer skills and experience where needed.

Managing Resource Gaps and Supply Chain Disruptions

 人手不足也影响到对临床试验研究至关重要的其他关键合作者，如供应商. For example, 因为相互竞争的研究和有限的人员配备可能导致从实验室收到检测结果的延迟, 我们的项目经理与团队一起仔细计划样品收集和测试，并跟踪现场和实验室，以确保发货, processing, and reporting are efficiently managed.

供应链延误会妨碍试验用品的交付，并中断临床试验的登记. To reduce this risk, 我们与现场和药物/实验室试剂盒供应商密切合作，以及时了解交货期, inventory, enrollment, and expirations to ensure that supply shortages are alleviated. 维护详细的跟踪报告有助于识别潜在的问题, so they can be addressed before enrollment goals are compromised. And throughout the study, open communication with managers, sites, 而供应商是保证临床试验顺利进行的关键.

Advancing Innovative Therapies Is the Goal

当今的经济气候加剧了临床试验行业面临的挑战. 趣赢平台’s dedicated CRO team of biostatisticians, clinical research associates, data managers, regulatory associates, 研究经理随时准备帮助赞助商克服这些挑战. Our innovative solutions support delivery of cost-efficient, productive, and highly successful clinical trial programs. We believe with the right partner, 小型生物技术和制药公司可以在这种环境中蓬勃发展，并将其创新药物和疗法成功推向市场.

Contributed by Christine Anderson, PhD, and Jennifer Bryant, MPA, CCRP, both of 趣赢平台’s Clinical Trials Area.