满足儿科药物研发中亟待满足的需求

儿科

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成功通过复杂的法规程序并满足相关要求

借助专家和专属团队实施合适的解决方案

通过早期应用数据驱动的深度见解,提高计划的成功率


As your expert partner in the pediatric clinical trial space, we efficiently work with highly specialized sites and investigators, determine family and patient motivations to participate and develop operational strategies to meet your needs while incorporating the families’ and patients’ voice throughout. 

About pediatric drug development

无论适应症是什么,儿科药物研发计划都会面临诸多共同的挑战。 Our dedicated team of pediatric experts are here to overcome these challenges by partnering with you to discuss options and develop pediatric tailored solutions.无论您是在进行候选药物的临床研发并考虑如何有效开展儿科临床研究以满足法规要求、通过递交书面申请探讨专利续期和排他性,或者在为某种罕见的儿科疾病开发治疗方案,专家团队都能助您一臂之力。

No question or need you have is too small and no challenge too large. You can look to us to deliver customized solutions at the project, program and compound level.

  • 2014年以来完成超过200次儿科临床试验,跨越大多数治疗领域,其中将近一半的试验涉及某种罕见病适应症
  • Investigator site performance data from Covance Central Labs involving approximately 50% of global clinical trials, more than 175,000 investigators and more than 15,000 protocols in 102 countries
  • Pediatrician medical advisors with diverse backgrounds and globally positioning ranging from general pediatrics to subspecialties within endocrinology, hematology/oncology, infectious diseases, neonatology, pharmacology, surgery and critical care
  • Rare disease and pediatric team aligned to assist you with strategy, proactive risk/issue mitigation, site relationship development and thought leadership

作为您在儿科临床试验领域的专家合作伙伴,我们能够高效地与高度专业化的试验中心及研究者合作,确定家庭与患者的参与动机,并制定运营策略以满足您的需求,同时在全过程中整合家庭和患者的反馈。您能够得到可信赖的深度见解与解决方案的其它一些领域包括:

  • 了解法规要求、递交途径以及与法规执行机构进行有关儿科计划的谈判
  • 参与患者权益组织、疾病和研究中心网络以及协议组织并与之建立合作伙伴关系。  Covance is a 2020 sponsor of the International Children’s Advisory Network
  • 加强与患者及其家属的联系,以强化复杂与疑难适应症的招募、入组和持续研究
  • Enhancement of trial design with data-driven insights, site identification, recruitment and endpoint development
按阶段和主要适应症划分的儿科研究

Meet our pediatric drug development team

Gina Calarco MPH, BSN, RN, CCRC

Gina Calarco MPH, BSN, RN, CCRC
运营战略和规划总监
罕见病和儿科团队

Ms. Calarco is a pediatric nurse with more than 15 years of experience in healthcare and drug development across a range of therapeutic areas including pediatrics, rare diseases, ophthalmology, respiratory, infectious diseases and vaccines. 她对新生儿群体有着特别的兴趣。
 
Prior to joining Labcorp in 2018, she served as associate director and deputy head of the Pediatric and Rare Diseases Center of Excellence for a major global contract research organization. She was also a prior senior clinical project manager for allergy, respiratory, infectious diseases and vaccines, in which she managed U.S. and international pediatric and adult Phase I-IV trials. Her nursing career began in a level IV neonatal intensive care unit and expanded into research, eventually managing clinical trials at a large pediatric academic center. She is a certified clinical research coordinator, a registered nurse in the state of Missouri and member of the American Academy of Pediatrics, Section on Advances in Therapeutics and Technology.

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