小児治験には特別な配慮が必要不可欠

There are specific needs and considerations associated with product development in the pediatric patient population, including the inclusion of patients and parents/guardians in the research study process, the critical focus on ensuring the safety and well-being of this vulnerable population, the complex regulatory and commercial environment associated with children and the fact that the pediatric population is not unique, rather consists of several age groups with different physiological features and development stages. These challenges demand that you partner with an experienced, multidisciplinary, cross-functional team that is passionate and focused on the needs of children and the development of therapies for them.

サイネオス・ヘルスの小児科コンソーシアムは、小児治験に特有のニーズを満たすフィット・ フォー・パーパス (Fit-for-Purpose)のソリューションを開発/提供します。

 

過去5年間に、サイネオス・ヘルスは以下を実施してきました。

  • >270 pediatric projects and consultancy agreements, enrolling over 100,000 pediatric patients and working with over 10,000 sites.  
  • We have experience running clinical trials across all study phases and regions from complex phase I PK / PD studies until late phase trials. 

 

弊社は、すべての治療領域で小児治験を実施してきました。以下はその実績です。ただし、これらに限定されません。 

  • Analgesia
  • 循環器系
  • Dermatology
  • Endocrinology / Metabolism
  • 消化器系
  • Hematology
  • Hepatology
  • Immunology and Inflammatory
  • 感染症
  • 腎臓内科
  • 神経科
  • Nutrition
  • オンコロジー
  • 眼科
  • 精神科
  • Respiratory and Allergy
  • Skeletal Diseases
  • 泌尿器科

小児科コンソーシアム:情熱あふれる専門家集団

We have developed our Pediatrics Consortium as a global and cross functional platform, consisting of people experienced in different fields of pediatric clinical and commercial drug development solutions. Within the Consortium are pediatricians, clinicians, study nurses and other therapeutic experts, pediatric regulatory consultants, site liaisons, medical writers, biostatisticians and rare disease experts, as well as commercial strategists. This enables us to deliver end-to-end, creative solutions as your pediatric development partner.

With our cross-functional approach, we leverage our expertise and knowledge of pediatric disease and our database of patient location, availability and site quality, combining this with operational expertise to ensure an optimal, feasible and recruitable protocol and high data quality.

薬事規制および商品化コンサルタントは、小児科領域の懸案事項に精通しているため、適切なデータパッケージを提供して、承認取得の成功確率および商業的利益を最適化します。小児治験の成功に重要課題について、弊社は、次の分野でお客様をお手伝いすることができます。

 

  • Pediatric regulatory guidance and regulatory services for FDA/EMA 
  • Program/plan development & writing
  • Modeling & Simulation
  • Study summary/protocol design & writing
  • Informed consent & assent forms
  • Pediatric site identification
  • Organization & management of DSMC
  • Pediatric medical consultancy
  • Medical monitoring by Pediatricians
  • Patient enrollment & retention documents & strategies for each pediatric age group

 

小児科コンソーシアムと提携することで、お客様はクリニカル事業とコマーシャル事業にまたがる広範な小児専門家チームへのアクセスが可能となり、小児医薬品開発の効率的かつ革新的なソリューションと最高品質の小児科データと付加価値を受けることができます。

 

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