1. Monitoring

InCROM CRO’s monitoring services are provided by a highly skilled team consisting of the team leader, main CRA, and assistant CRA. Each is assigned the optimal number of studies for best cost efficiency. In addition to being InCROM experienced, the team is experienced with a wide array of therapeutic areas, allowing seamless work flow and communications with InCROM (SMO) and Heishinkai Medical Corporation.

Strengths of InCROM CRO’s Monitoring

✓Therapeutic experience rich team
✓Closely-linked team
✓All CRAs are capable of independently running projects end-to-end

• High, uniform and consistent quality
• High response speed at even atypical challenging requests

✓Well located adjacent to Heishinkai Medical Corporation’s early phase expert site, OPHAC Hospital
✓Good visibility to InCROM Group’s affiliated site network

• Closely linked with CRCs of InCROM (SMO) and the IRB offices of the affiliated facilities
• Monitoring conducted with outstanding efficiency and reliable quality
• Cost competitive

Monitoring Services

Pre-Study
• Risk Assessment
• Site and Investigator Selection
• Investigator Briefing and Consent
• Clinical Trial Request and IRB Q&A
• Contracting

On-Study
• Risk Management
• Start-Up Meeting
• Delivery of Investigational Drugs / Devices
• Informed Consent Confirmation
• Confirmation of Eligibility
• Management of Safety Information, AE, and Associated Communications with Sites
• Confirmation of Documents Archiving
• SDV
• CRF Inspection and Collection
• Monitoring Reports Development

Post-Study
• Risk Reporting
• Returns of Investigational Drugs / Devices
• Study Close-Out

2. Data Management

From Phase I to post-marketing surveillance, we are proficient in flexibly responding to any requests. It is possible due to our vast experience working with many different facilities, CRF types, and EDCs. We also support CDISC standards. Our Data Science Department houses both the data management team and statistical analysis team, enabling us quickly and seamlessly resolve any unexpected issues arisen from the independent work processes. Having both teams in the same department also allows for resource allocation optimization with ease.

Strengths of InCROM CRO’s Data Management

✓Robust experience with CRF and EDC types
✓Majority of the team are experts with more than 10 years of experience
✓Regular participation in CJUG (CDISC Japan User Group) for continuous skills improvement
✓Seamless communications between data management and statistical analysis
✓Dedication to close, thorough communications to ensure optimal workflow is proposed

Data Management Services

• Data Management Plan Development
• Database Structure Definitions Development
• Data Entry Manual Development
• Manual / Logical Checklists Development
• Database / Data Entry System Build
• EDC Setup
• EDC UAT
• Manual / Logical Check
• Database Validation
• Data Entry / Validation
• CRF Query Creation
• Medical Coding (MedDRA, Drug Data Files, WHO-DD)
• Case Review Meeting Preparation
• Data Lock
• DM Reports Development

3. Statistical Analysis

From Phase I to post-marketing surveillance, we are proficient in flexibly responding to any requests. SAS technicians with a wealth of expertise are involved in statistical analysis services. We also provide consulting services by expert biostatisticians. Our Data Science Department houses both the data management team and statistical analysis team, enabling us quickly and seamlessly resolve any unexpected issues arisen from the independent work processes. Having both teams in the same department also allows for resource allocation optimization with ease.

Strengths of InCROM CRO’s Statistical Analysis

✓Statistical analysis expert with over 40 years of experience working at top pharmaceutical companies
✓On staff SAS® 9 certified professionals
✓Majority of the team are experts with more than 10 years of experience
✓On staff statistical analysis experts, allowing us to offer a variety of proposals
✓Flexible solutions catering toward different client needs, e.g. PK analysis only instead of full scope
✓Seamless collaboration between data management team and statistical analysis team

Statistical Analysis Services

• SAP Development
• Mock-Up Development
• Data Set Development
• PK Parameters Calculation per WinNonlin
• Analysis Reports Development

4. CDISC support

Our staff fluent in CDISC (Clinical Data Interchange Standards Consortium), a mandate for new drug market approval applications since 2016 when submitting pivotal clinical trial data, ensure that CDISC standards are abided by.

CDICS Services

• SDTM Mapping Specifications Development
• Annotated CRFs Development
• SDTM Data Conversion Program Development
• ADaM Mapping Specifications Development
• ADaM Data Conversion Program Development
• Validation by Pinnacle (SDTM/ADaM)
• Define-XML (SDTM/ADaM) Development
• Study/Analysis Data Reviewer’s Guide Development
• Legacy Data Conversion Support (Non-CDISC format to CDISC format)

5. Medical Writing

Our medical writing team includes ex pharma professionals with clinical pharmacology background. Their rich industry experience and medical writing expertise, in addition strong English proficiency (Cambridge Certificate of Proficiency), enable us to be highly capable of producing trial-related documents in English as well. Furthermore, physicians at Heishinkai Medical Corporation can be consulted as needed.

Strengths of InCROM CRO’s Medical Writing

✓Medical writers who worked at pharmaceutical companies and have clinical pharmacology background
✓Capable of developing clinical trial protocols and other trial-related documents for foreign and Japanese pharmaceutical companies.
✓Strong bilingual resources with robust experience supporting global trials and overseas clients
✓On staff J/E expert translators who are also fluent in clinical trial industry translations
✓Easy access to Heishinkai Medical Corporation clinical trials physicians for consultation
✓High response speed and flexibility to even sudden schedule changes

Medical Writing Services

• Drafting of clinical trial protocols
• Drafting of informed consent documents
• Drafting of investigator’s brochures
• Drafting of clinical study reports
• Drafting of journal articles

6. Audits

Auditing Services

• Audit Plans Development
• GCP Audits (medical institutions and CROs)
• Audit Reports Development
• Audit Certificates Development

7. Other Services

• Consulting services, e.g. study design
• Journal Articles Development Support