Alira Health
Alira Healthは、医薬品や医療機器の初期開発から、臨床試験や薬事申請、マーケットアクセスに至るまで、製品のライフサイクル全体の支援を行っている企業です。同社は、特にCMC（化学・製造・品質管理）や薬事戦略などに強みを持っており、患者中心のアプローチによって企業の開発戦略を総合的にサポートしています。こちらのページでは、Alira Healthの特徴や強みなどを調査してまとめました。
Alira Healthが請け負う非臨床試験
非臨床試験のデザインと戦略の立案を行う
新薬の候補におけるPoC（概念実証）に向けた、非臨床試験の予算策定やデザイン、スケジュールの立案についてサポートを行います。FDAやEMAなどの規制当局による要件に基づいた薬理・毒性試験に対する戦略的なアプローチを構築し、のちに実施される臨床試験にスムーズに移行するためのロードマップを提供することによって、開発に関するリスク低減に繋げていきます。
外部CRO・CDMOの選定
Alira Healthは実験施設（ラボ）を持っていないことから、顧客のニーズや開発品目に適した外部のCDMOやGLPに対応したCROの選定を行います。マスターサービス契約の交渉支援や技術的な監督、品質管理のマネジメントを顧客に代わって行い、外部委託先で行っている非臨床試験が、スケジュール通りに進むように取り組みます。
薬事およびCMCと連動した支援
非臨床試験における計画や実行を単独で終わらせるのではなく、CMC（化学・製造・品質管理）や薬事戦略との連携を行います。非臨床試験で用いる毒性試験用ロットの製造指揮、分析方法の開発や適格性評価のサポートを行っており、試験の実施によって得られたデータを、規制当局に提出するための申請資料の作成まで一貫して支援The company is doing so.
Alira Healthが取り扱う受託会社紹介
公式ホームページでは、Alira Healthが提携・取り扱っている特定の外部受託会社（CROやCDMO）に関する情報はありませんでした。
Alira Healthの非臨床試験事例
Alira Healthの非臨床試験事例は公式ホームページに掲載されていませんでした。
Alira Healthの企業情報
| Address |
1 Grant Street, Suite 400, Framingham, MA 01702, USA |
| Tel |
+1-774-777-5255 |
| Website |
https://alirahealth.com |
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise
In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D.
In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening.
Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.
Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
- SMC Laboratories, Inc. has established a disease models using patented mouse technologies.
The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
- From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project.
Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.
- With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies
Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc.
(Labcorp Drug Development)
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
- Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements.
All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
- The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
- Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials.
For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
- PhoenixBio Co., Ltd.offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
- With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
- The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics.
For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
Japanese