Clinical Development Services
The foundation for excellence in clinical research
Whether you are in need of one or more specific capabilities or seeking a strategic functional service provider (FSP) partnership, we can help.
Across a full range of clinical development services, we offer the deep expertise, operational excellence and advanced technologies you need to navigate the complexities of today’s clinical trial environment.
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Biostatistics & Statistical Programming Services
Whether it’s a small first-in-human exploration or an international clinical trial, our global Biostatistics and Clinical Programming services team brings technical expertise and efficiencies to projects of all sizes, through all phases of clinical development and commercialization.
Accuracy when it counts – which means always
Our standardized processes, validated technologies and experienced staff prepare tables, figures and listing outputs in advance of database lock, helping you make swift internal decisions and communicate effectively with the public, partners and/or investors.
Offering analysis and reporting services to meet every need, including:
- 高度な統計コンサルティング
- 包括的なSAP（統計解析計画）
- 自動応答技術（IRT）の要件に従って生成される無作為化スケジュール
- 業界標準と動向に一致した申請準備データセットと補足用のメタデータ
- 盲検／非盲検（例：中間およびDMC解析）のTLF（表、リスト、図）、独自の統計報告
Clinical Data Management Services
Combining the latest technologies with years of data management experience, our global Clinical Data Management services team adopts an intelligent approach to developing and implementing quality data collection solutions. With a focus on a streamlined, effective route to database lock, we utilize a suite of techniques to identify and resolve data discrepancies and assure data quality.
We strive for real time readiness and believe in data transparency
We use novel approaches and tools to monitor and report on data quality and progress and keep our customers up to date with performance throughout the project. Quality and risk management are embedded are every step to facilitate early risk/issue detection, feed vital information to the project team and provide an adaptive approach to monitoring and trial delivery.
Industry-leading EDC solutions and technology innovation
We specialize in customized solutions to accommodate project-based or flexible functional service provider models. 弊社のチームは、業界トップの臨床データベースシステムのすべてに熟練しており、過去15年以上にわたり実施したEDC試験の数は、進行中の試験を含め1,700件超に上ります。
Clinical Monitoring Services
A clinical trial has many complex, moving parts and each must be monitored to protect the safety of study participants and data integrity while keeping the study running according to protocol and regulatory requirements.
Streamlining strategy to mitigate risks and drive data integrity in clinical trial monitoring
We take a risked-based monitoring (RBM) approach to developing and executing monitoring strategy, using comprehensive dashboards customized to the specific risks of each trial.
Orchestrated by the clinical trial manager, our highly-skilled central monitors (CTs) and clinical research associates (CRAs) collaborate closely and work in sync along with our risk managers and RBM subject matter experts to resolve concerns swiftly so that patients stay safe, studies stay on schedule and results remain robust.
これにより、次の成果が得られています。
• Issues are detected 20% faster than by traditional monitoring methods
• 40% of queries and protocol deviations are detected by our CMs so that CRAs can focus on taking corrective actions with sites
Developing new clinical talent
Our Clinical Monitoring team members perform crucial roles in patient safety, site and study compliance and clinical data integrity. プロジェクトを成功させるには、これらの役割の人員配置と一貫性が最も重要です。Our Clinical Training Institute and Oncology Academy, accredited by the International Accrediting Organization for Clinical Research (IAOCR) helps us maintain a talent pool of CRAs focused on high-quality project delivery. We’re building better CRA teams with first-in-industry immersive virtual workforce training.
Medical Writing Services
弊社のメディカルライティングの専門知識は、前臨床報告から医薬品開発プロセス、市販後臨床試験、そして商品化に向けた文書作成に至るまで、幅広い治療領域と文書タイプをカバーしています。Our services include:
- 治験実施計画書および改訂文書
- 治験薬概要書（IMPD）
- 同意文書・説明文書および患者用リーフレット
- 治験総括報告書（完全、簡素、暫定、要約）
- 患者レベルおよび事象レベルの安全性情報の記述
- 年次報告書
- 概要説明書
- 治験薬概要書（IB）
- 研究新薬（IND）の申請書、新薬販売に対するFDA承認申請書（NDA）、コモン・テクニカル・ドキュメント（CTD）提出資料
- 規制当局への対応
- リスクプロファイル
- 定期的安全性最新報告（PSUR）
- 定期的ベネフィット・リスク評価報告（PBRER）
- 米国食品医薬品局の定期ラインリスト
- リスク管理計画（RMP）
- 開発時定期的安全性最新報告（DSUR）
- 地域ごとの安全性概要（local safety summaries; LSS）
- シグナル分析
- 臨床に関する概括評価
- 公表のためのメディカルライティング
- 公表計画およびジャーナル投稿の支援
- 文献レビューおよび文献検索
- 口頭プレゼンテーション、ポスター、および要約書
- スライド一式
- 医療情報レター
- 諮問委員会のスライド作成
- 申請サポート
- 文書の作成管理
- 申請文書の最終化および公表
- 臨床試験の透明性の確保および情報開示
- 一般向けの文書
- 文書の改訂
- 臨床研究登録レジストリのサポート
- 規制当局への提出資料目録
TMF業務
臨床試験が大規模かつ複雑になると、関連する部署やパートナーの数が増えます。結果としてTMF（治験マスターファイル）の管理が難しくなることがあります。We are a specialist provider of technology-enabled eTMF solutions and other support services for the global clinical research market.
Our skilled, dedicated team manages the TMF process with a focus on quality and compliance, and we’re here to help ensure success for your trial. 完全で正確、そしてタイムリーなTMF文書ファイル処理は、サイネオス・ヘルスが誇る最も重要なサービスの1つです。Our services include:
- TMF completeness reviews
- TMF inspection readiness evaluations
- TMF migration planning/remediation
- TMF transition/conversion
- TMF consultancy services
- Document processing services
- TMF management services
Rater Training Services
評価者トレーニングのスペシャリストは、最終的にお客様データの品質および一貫性の向上につながる、テスト事務と試験の採点／行動評価スケールの品質および一貫性の改善に取り組んでおります。
Our team members are highly experienced clinical psychologists, neuropsychologists, psychometrists and assessment specialists who have extensive global experience in providing rater training. They provide expert, comprehensive rater evaluation, rater training and rater scales management services coupled with unparalleled scientific, technical and procedural support.
弊社は、多施設共同試験のための評価者トレーニング、評価者の評価（セントラルレーティングレビュー）、文書管理（翻訳、ハーモナイゼーション、著作権、業務工程表）、および電子化された神経心理学的評価に関して、最も信頼性の高い情報源として、ご期待にお応えします。
Clinical Trial Investigator Management Services
We are dedicated to ensuring our customers obtain the quality clinical research data they need to get medical treatments to patients sooner. To do this it’s essential that clinical trial principal investigators and sites are happy with the clinical trial payment process and we achieve this through automation, industry-leading transparency reporting capabilities, and integrated data management and site contracting. We remove pain points by:
- Assigning a dedicated, single point of contact at the CRO or sponsor to handle financial matters
- Communicating the payment escalation process at the beginning of each study
- Making sure sites receive monthly clinical trial payment
- Making the process simple, fast, transparent and efficient through use of our proprietary online tool
- Providing top-line simultaneous notification of payments received and pending for speedier and more efficient reconciliation
- Reducing the number of invoices that sites are required to generate and removing holdback clauses wherever possible
Learn more about what we offer and how we partner.
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