小児医薬品

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

小児用医薬品開発プログラムは、症状にかかわらず共通の課題を抱えています。 Our dedicated team of pediatric experts are here to overcome these challenges by partnering with you to discuss options and develop pediatric tailored solutions. たとえば、医薬品候補の臨床開発において、承認申請の要件を満たす小児臨床研究を効率よく実施するにはどうすればよいか思案されている場合、あるいは、特許期間の延長を検討されていて、書面による出願の条件を履行して独占権の取得を考えておられる場合、希少小児疾患の治療に取り組まれている場合など、当社の専門家がお手伝いします。

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、200 件を超える小児試験が多くの治療分野で行われており、そのうち約半数の試験が希少疾患の症状に関係があります。
• 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

コーヴァンスは小児治験領域における専門家パートナーとして、非常に特化した施設で治験責任医師・分担医師と効率よく連携し、患者様やご家族の参加動機を見極めて、その声を全体に反映させながらお客様のニーズに合う業務戦略を立てることができます。また、次のような領域においてもお客様に確かな知見とソリューションをご提供します。

• 規制要件、申請の手順、規制当局との交渉（小児関連の計画について）の理解
• 患者様支援団体、疾患・施設ネットワーク、コンソーシアムとの間におけるエンゲージメントおよびパートナーシップ。  Covance is a 2020 sponsor of the International Children’s Advisory Network
• 複雑で困難な適応症を扱う治験のリクルート・参加の促進、および進行中の治験に対するエンゲージメント向上を目指した、患者様とその家族の関与
• Enhancement of trial design with data-driven insights, site identification, recruitment and endpoint development

Meet our pediatric drug development team

Gina Calarco（MPH、BSN、RN、CCRC）
運営戦略・企画担当ディレクター
希少疾患・小児科チーム

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. 彼女は新生児の集団に特別な関心を持っています。
 
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.