Where U.S. clinical experience meets Japanese precision.
GCP-certified clinical research professional specializing in Japanese–English medical translation, US–Japan pharmaceutical consulting, and in vitro diagnostic device trial support. Serving pharmaceutical, biotechnology, and IVD organizations across US and Japan markets.
Translation is not conversion. It is understanding.
A protocol means nothing if the cultural weight behind it is lost. A consent form is not just a legal document - it is a conversation. At Kakehashi Clinical, we work in the space where clinical precision and cultural fluency are not traded off against each other. They are the same thing.
渡
01
Japanese–English Medical Translation
Clinical trial protocols, ICFs, regulatory submissions - translated by someone who has actually worked inside regulated clinical environments.
02
US–Japan Clinical Research Consulting
Japanese pharma entering the U.S. market. U.S. organizations working with Japanese sponsors or sites. I bridge the regulatory, cultural, and operational gaps.
03
Life Sciences Marketing & Localization
Biotech and health brands expanding across the Pacific. Content that communicates precisely in both languages - and both cultures.
04
Regulatory & SOP Documentation
Audit-ready SOPs and regulatory documents, drafted or translated across English and Japanese.
術
Services
Four disciplines. Executed with precision.
Every service I offer sits at the intersection of clinical science, Japanese language, and cross-border operations across drug and device clinical research. I work directly with you on every project - no handoffs, no agencies.
Who We Serve
Kakehashi Clinical works with organizations where the distance between US and Japanese clinical research systems creates friction. That friction is where we operate.
Japanese pharmaceutical companies entering US clinical markets
US biotechnology and pharmaceutical organizations with Japanese sponsors or sites
Medical device and in vitro diagnostic manufacturers
Contract research organizations managing cross-border trials
Clinical research sites preparing for sponsor or regulatory audit
Biotech startups building regulatory documentation infrastructure
Academic research institutions with international collaboration
Healthcare and life sciences organizations requiring Japanese-English communication
01
医学翻訳
Japanese–English Medical Translation
Unlike general translators, I bring a biology degree and active GCP-compliant clinical trial experience to every document. Scientific precision and linguistic fluency - together.
Clinical Trial Protocols & Amendments
Informed Consent Forms (ICFs)
Regulatory Submissions & Dossiers
Scientific Abstracts & Manuscripts
Patient-Facing Materials
Who This Is For
Pharma, biotech, IVD manufacturers, and CRO teams working across US and Japanese markets who need translation that is scientifically accurate, not just linguistically correct.
Japanese sponsor entering US IND process
US CRO managing Japanese-language site documents
Regulatory affairs team preparing bilingual submissions
IVD manufacturers entering Japanese or US markets requiring device-specific regulatory translation
Per-project flat rates available for larger documents. Contact for a quote.
02
コンサルティング
US–Japan Clinical Research Consulting
Specialized support for Japanese pharma and device companies operating in the U.S., and U.S. organizations working with Japanese sponsors or sites. Spanning both drug and device clinical research, including in vitro diagnostic trials regulated under ISO 14155 and FDA 21 CFR Part 820 frameworks, with direct experience in ISO 13485-regulated IVD product environments. For Japanese pharmaceutical and device organizations, this includes orientation to structural differences between FDA and PMDA regulatory frameworks - critical context for cross-border trial planning and document preparation.
GCP Compliance Review
Protocol & Eligibility Criteria Review
Cross-Cultural Trial Coordination
Regulatory Document Review
Site Communication Support
Who This Is For
Japanese pharmaceutical, medical device, and IVD companies entering the U.S. clinical trial space, or U.S. research organizations whose sites, sponsors, or documentation involve the Japanese market.
Japanese sponsor conducting first US Phase II trial
US organization with Japanese-only site documents
CRO needing bilingual compliance support
Medical device and IVD companies navigating PMDA or FDA regulatory pathways
Remote & async · Monthly retainers available · All deliverables GCP-compliant
Pricing
$75–125
per hour
Monthly retainers available for ongoing engagements. Project-based pricing also available.
03
マーケティング
US–Japan Life Sciences Marketing & Localization
Expanding into a new market means more than translation - it means understanding how the audience thinks, what they trust, and what builds credibility. I bring both the science and the cultural fluency.
Website & Digital Localization
Scientific Content Writing (EN/JP)
Brand Messaging for Cross-Border Audiences
Conference & Presentation Materials
Who This Is For
Biotech and health brands expanding into the U.S. or Japanese market for the first time, who need someone with genuine scientific credibility and bilingual fluency.
Japanese health tech brand launching US campaign
US biotech entering Japanese conference circuit
Pharma brand needing bilingual digital presence
Custom project or retainer · Fully remote · Contact for pricing
Pricing
Custom
project or retainer
Scope and pricing determined after an initial conversation about your goals and timeline.
04
規制文書・SOP作成
Regulatory & SOP Documentation
Regulatory documentation is the backbone of every compliant operation. Whether you need existing SOPs translated between English and Japanese, new SOPs drafted for a regulated environment, or quality documentation prepared for cross-border review, this service delivers precise, audit-ready output grounded in real regulated-environment experience across GCP, GMP, and ISO-based quality systems.
SOP Translation (EN/JP)
Regulated SOP Drafting
Quality Documentation Review
Cross-Border Document Preparation
Who This Is For
Biotech startups building out their quality systems. Clinical sites preparing for sponsor or regulatory audit. Japanese organizations entering US operations who need English-language SOPs. US organizations with Japanese partners requiring bilingual documentation. Small CROs without dedicated regulatory writing staff.
Quality systems needing bilingual SOP infrastructure
Drafting, translation, and review · Audit-ready formatting · Flat rates available
Pricing
$0.18–0.25
per word for translation
Drafting: $95–125/hr. Per-word rates for translation; hourly or project-based for drafting. Flat rates available.
架
About
Science. Language. Two worlds, one bridge.
I'm Chadwin Bush - a GCP-certified clinical research professional with deep scientific training, experience supporting ISO 13485, GMP, and ISO-classified cleanroom operations, and advanced professional Japanese fluency built entirely through self-study and immersion.
98.1
JLPT N2 Percentile Rank
8
Professional Certifications
4
Regulated Scientific Environments
道
My Story
"I taught myself Japanese from zero. What started as curiosity became a years-long daily commitment that eventually took me to Tokyo."
I didn't take a class. I didn't use a tutor. I built my Japanese proficiency entirely through self-directed study - daily vocabulary review, immersive media, and real conversation with native speakers. Scoring in the 98.1st percentile on the JLPT N2 - with a perfect 60/60 on the listening section - is proof that consistency over time produces extraordinary results.
That same discipline carries into my scientific work. That experience spans four distinct regulated environments: GCP-governed clinical trial operations, ISO 13485 and GMP-regulated in vitro diagnostic product testing, ISO-classified cleanroom tissue processing, and aseptic biological manufacturing. Each environment demanded precision, documentation rigor, and zero-margin-for-error standards.
I founded Kakehashi Clinical because I saw a gap very few people can fill: the space between U.S. clinical research operations and the Japanese pharmaceutical market. When you work with me, you work with me directly. I am personally accountable for every deliverable.
I am currently pursuing JLPT N1 through daily study - the highest level of Japanese language certification - and remain actively embedded in clinical trial operations.
Founder
Chadwin Bush
Principal Consultant · Nashville, TN · Available Worldwide
Languages
English · 日本語
Advanced professional fluency · JLPT N2 certified · N1 in progress
"Clinical precision. Cultural fluency. The space where both become one."
空気を読むReading the air - understanding what is meant but never said
Japanese is not just a language I studied. It is a culture I fell into, friendships that became family, a way of seeing the world that changed how I think about communication itself. 空気を読む - reading the atmosphere, understanding what is implied but left unsaid - is not a translation technique. It is a way of being present. That is what I bring to every document, every consultation, every client relationship. Translation that is only word-for-word is not translation. It is transcription. True translation carries the nuance, the implication, the meaning between the lines - the purple that emerges when two distinct worlds are allowed to meet.
旅
Time In Japan
Not a tourist. Embedded in the culture.
Senso-ji Temple, Asakusa - Tokyo
Shabu-shabu dinner with a colleague - Tokyo
Company sports day - Blued Co., Shibuya
Halloween party at the office - Blued Co., Tokyo
和
Our Paradigm
Two distinct markets.One bridge.
紫Bridge
United States
Red · White · Blue
日本 · Japan
Crimson · White
"Japan's 日の丸 and the American flag share one color: red. Add the blue of U.S. clinical science, and you get purple. That is exactly where Kakehashi Clinical operates."
青と赤が交わると紫になる。二つの国が出会う場所。
歴
Experience
A track record built across regulated environments.
Dec 2025 Present
Clinical Trial Screening Specialist
Link Clinical · Remote, US
Perform comprehensive secondary screening to evaluate patient eligibility, reviewing medical history and applying protocol inclusion/exclusion criteria to ensure high-quality referrals. Coordinate with site staff and investigators to support enrollment targets and maintain GCP-compliant documentation across all screening activities. Experience encompasses both drug and device clinical trial operations.
Performed microbiological testing on raw materials and finished products ensuring quality and safety compliance. Maintained strict aseptic technique, accurate documentation, and adherence to GMP and ISO standards.
GMPISOMicrobiologyAseptic Technique
Jan 2025 Oct 2025
Ocular Processing Coordinator
DCI Donor Services · Nashville, TN
Performed aseptic processing of human tissues and autologous serum eye drops (ASED) in a controlled cleanroom environment under strict SOP and regulatory compliance. Coordinated specimen collection workflows including phlebotomy, labeling, and documentation ensuring full traceability.
Worked fully embedded in a Japanese company in Shibuya, Tokyo - operating entirely in Japanese in a professional setting. Managed social media platforms, developed content strategy, and increased engagement 10x in the first week. Built lasting professional relationships with Japanese colleagues.
日本語TokyoSocial MediaContent Strategy
Jun 2024 Oct 2024
Associate Biochemist
QuidelOrtho Corporation · Athens, OH
Conducted regulated testing of raw materials and in vitro diagnostic finished products under ISO 13485 and GMP guidelines in an environment subject to FDA and international regulatory inspection. IVD finished product testing in an FDA and internationally regulated environment, including audit-ready documentation and BSL-2 agent handling. Documented and reviewed laboratory data supporting audit readiness and regulatory inspections. Applied biochemistry experience and BSL-2 agent handling to validate product integrity.
ISO 13485GMPIn Vitro DiagnosticBSL-2Audit Readiness
Aug 2020 May 2024
B.S. Biological Sciences
Ohio University · Athens, OH
Minor in Healthcare Administration. Coursework spanning microbiology, biochemistry, human anatomy, physiology, and healthcare systems. Foundation for all subsequent regulated scientific work.
BiologyHealthcare AdministrationBiochemistry
信
Credentials
Every certification. Verified.
Primary Certifications
GCP Certificate Preview
Good Clinical Practice (GCP)
NIDA Clinical Trials Network
Completed June 1, 2026 · All 11 Modules Passed · Valid Through June 2029
Shipping & Transport Of Regulated Biological Materials
CITI Program
Valid Through July 2027
救急
CPR / AED / ERT
QuidelOrtho Corporation
Valid Through July 2026
縁
Contact
Let's work together.
Whether you need a document translated, a protocol reviewed, or an ongoing consulting partner for your US–Japan operations - I respond to all inquiries within one business day.
