안전성 평가 - 독성자료전산화
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시험 데이터의 정확성 및 안전성을 위해서 Instem사의 Provantis® Preclinical및 SEND 제출 위한 데이터 변환 Submit™ SEND을 도입하였습니다.
Provantis® Preclinical
시험계획서의 입력부터 동물사육, 일반증상관찰, 임상병리, 부검, 조직병리, 통계분석, 데이터 결과보고서까지의 모든 과정을 전산시스템으로 자동화하였습니다.
- Protocol Definition
- 시험 계획서 셋업 및 스케줄 작성
- Animal Management
- 동물 정보, Balance 측정, 음수, 물 섭취 등
- Clinical Pathology
- 임상 병리기기 데이터 입력
- Pathology
- 부검 소견, 조직병리 입력
- General Toxicology
- 일반 독성
- Reproductive Toxicology
- 생식 독성
- Tables & Statistics
- 테이블 및 통계
- Data Exchanger
- 외부 데이터 입력
SEND(Standard for the Exchange of Nonclinical Data)
SEND-compatible electoronic data submissions became mandatory for US FDA
applications for specific nonclinical studies starting after December 17, 2017.
Chemon Inc. not only provides SEND datasets, but also offers total support
for US FDA SEND application process.
- Using this system, Centrus solutions
The loss of enormous amounts of time and money due to Refuse to File by FDA.
- SEND external cooperation(INA, PDS Inc) Enhance
a. SEND service capabilities Enhance
b. US FDA policy Partnership
- Get the total Package
We reduce client workload and stress by offering total support for Creating
SEND Packages
- Complete QC system
SEND professionals work under GLP organization, providing high-quality SEND packages.
- Pathological support
Well experienced pathologists are on-hand to share their knowledge on
pathological findings Using Send Controlled Terminologies.
Submit™ SEND
비임상데이터의 SEND 데이터세트를 만들기 위한 과정을 프로세스화하고 있습니다.
- Submit Requestor
- Create Send dataset
- SubmitTM
a. review the dataset
b. reslove errors & Investigate warning
SENDViewTM
a. Apply data Edit Rules, Translation
b. Re-Run the dataset
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Controlled Terminology
- Send 3.0 & Provantis Terms Mapping
- DataDefineTM
- Create Define files(XML)
- Nonclinical Study Data Reviewer Guide(NSDRG)
- FDA Reviewers and Data Managers provides additional context for send datasets
received as part of a regulatory submission.
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