{"id":156,"date":"2022-05-23T10:11:18","date_gmt":"2022-05-23T01:11:18","guid":{"rendered":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/?p=156"},"modified":"2023-08-07T16:49:24","modified_gmt":"2023-08-07T07:49:24","slug":"service","status":"publish","type":"post","link":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/cro\/service\/","title":{"rendered":"InCROM CRO services"},"content":{"rendered":"

1. Monitoring<\/h3>\n

\"\"<\/p>\n

InCROM CRO\u2019s 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.<\/p>\n

Strengths of InCROM CRO\u2019s Monitoring<\/h4>\n

\u2713Therapeutic experience rich team
\n\u2713Closely-linked team
\n\u2713All CRAs are capable of independently running projects end-to-end<\/p>\n

\u2022 High, uniform and consistent quality
\n\u2022 High response speed at even atypical challenging requests<\/b><\/div>\n

\u2713Well located adjacent to Heishinkai Medical Corporation\u2019s early phase expert site, OPHAC Hospital
\n\u2713Good visibility to InCROM Group\u2019s affiliated site network<\/p>\n

\u2022 Closely linked with CRCs of InCROM (SMO) and the IRB offices of the affiliated facilities
\n\u2022 Monitoring conducted with outstanding efficiency and reliable quality
\n\u2022 Cost competitive<\/b><\/div>\n

Monitoring Services<\/h4>\n

Pre-Study<\/b>
\n\u2022 Risk Assessment
\n\u2022 Site and Investigator Selection
\n\u2022 Investigator Briefing and Consent
\n\u2022 Clinical Trial Request and IRB Q&A
\n\u2022 Contracting<\/p>\n

On-Study<\/b>
\n\u2022 Risk Management
\n\u2022 Start-Up Meeting
\n\u2022 Delivery of Investigational Drugs \/ Devices
\n\u2022 Informed Consent Confirmation
\n\u2022 Confirmation of Eligibility
\n\u2022 Management of Safety Information, AE, and Associated Communications with Sites
\n\u2022 Confirmation of Documents Archiving
\n\u2022 SDV
\n\u2022 CRF Inspection and Collection
\n\u2022 Monitoring Reports Development<\/p>\n

Post-Study<\/b>
\n\u2022 Risk Reporting
\n\u2022 Returns of Investigational Drugs \/ Devices
\n\u2022 Study Close-Out<\/p>\n

2. Data Management<\/h3>\n

\"\"<\/p>\n

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.<\/p>\n

Strengths of InCROM CRO’s Data Management<\/h4>\n

\u2713Robust experience with CRF and EDC types
\n\u2713Majority of the team are experts with more than 10 years of experience
\n\u2713Regular participation in CJUG (CDISC Japan User Group) for continuous skills improvement
\n\u2713Seamless communications between data management and statistical analysis
\n\u2713Dedication to close, thorough communications to ensure optimal workflow is proposed<\/p>\n

Data Management Services<\/h4>\n

\u2022 Data Management Plan Development
\n\u2022 Database Structure Definitions Development
\n\u2022 Data Entry Manual Development
\n\u2022 Manual \/ Logical Checklists Development
\n\u2022 Database \/ Data Entry System Build
\n\u2022 EDC Setup
\n\u2022 EDC UAT
\n\u2022 Manual \/ Logical Check
\n\u2022 Database Validation
\n\u2022 Data Entry \/ Validation
\n\u2022 CRF Query Creation
\n\u2022 Medical Coding (MedDRA, Drug Data Files, WHO-DD)
\n\u2022 Case Review Meeting Preparation
\n\u2022 Data Lock
\n\u2022 DM Reports Development<\/p>\n

3. Statistical Analysis<\/h3>\n

\"\"<\/p>\n

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.<\/p>\n

Strengths of InCROM CRO\u2019s Statistical Analysis<\/h4>\n

\u2713Statistical analysis expert with over 40 years of experience working at top pharmaceutical companies
\n\u2713On staff SAS\u00ae 9 certified professionals
\n\u2713Majority of the team are experts with more than 10 years of experience
\n\u2713On staff statistical analysis experts, allowing us to offer a variety of proposals
\n\u2713Flexible solutions catering toward different client needs, e.g. PK analysis only instead of full scope
\n\u2713Seamless collaboration between data management team and statistical analysis team<\/p>\n

Statistical Analysis Services<\/h4>\n

\u2022 SAP Development
\n\u2022 Mock-Up Development
\n\u2022 Data Set Development
\n\u2022 PK Parameters Calculation per WinNonlin
\n\u2022 Analysis Reports Development<\/p>\n

4. CDISC support<\/h3>\n

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.<\/p>\n

CDICS Services<\/h4>\n

\u2022 SDTM Mapping Specifications Development
\n\u2022 Annotated CRFs Development
\n\u2022 SDTM Data Conversion Program Development
\n\u2022 ADaM Mapping Specifications Development
\n\u2022 ADaM Data Conversion Program Development
\n\u2022 Validation by Pinnacle (SDTM\/ADaM)
\n\u2022 Define-XML (SDTM\/ADaM) Development
\n\u2022 Study\/Analysis Data Reviewer’s Guide Development
\n\u2022 Legacy Data Conversion Support (Non-CDISC format to CDISC format)<\/p>\n

5. Medical Writing<\/h3>\n

\"\"<\/p>\n

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.<\/p>\n

Strengths of InCROM CRO’s Medical Writing<\/h4>\n

\u2713Medical writers who worked at pharmaceutical companies and have clinical pharmacology background
\n\u2713Capable of developing clinical trial protocols and other trial-related documents for foreign and Japanese pharmaceutical companies.
\n\u2713Strong bilingual resources with robust experience supporting global trials and overseas clients
\n\u2713On staff J\/E expert translators who are also fluent in clinical trial industry translations
\n\u2713Easy access to Heishinkai Medical Corporation clinical trials physicians for consultation
\n\u2713High response speed and flexibility to even sudden schedule changes<\/p>\n

Medical Writing Services<\/h4>\n

\u2022 Drafting of clinical trial protocols
\n\u2022 Drafting of informed consent documents
\n\u2022 Drafting of investigator\u2019s brochures
\n\u2022 Drafting of clinical study reports
\n\u2022 Drafting of journal articles<\/p>\n

6. Audits<\/h3>\n

\"\"<\/p>\n

Auditing Services<\/h4>\n

\u2022 Audit Plans Development
\n\u2022 GCP Audits (medical institutions and CROs)
\n\u2022 Audit Reports Development
\n\u2022 Audit Certificates Development<\/p>\n

7. Other Services<\/h3>\n

\u2022 Consulting services, e.g. study design
\n\u2022 Journal Articles Development Support<\/p>\n","protected":false},"excerpt":{"rendered":"

1. Monitoring InCROM CRO\u2019s 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 […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[],"class_list":["post-156","post","type-post","status-publish","format-standard","hentry","category-cro"],"_links":{"self":[{"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/posts\/156","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/comments?post=156"}],"version-history":[{"count":7,"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/posts\/156\/revisions"}],"predecessor-version":[{"id":345,"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/posts\/156\/revisions\/345"}],"wp:attachment":[{"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/media?parent=156"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/categories?post=156"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/incrom.kir.jp\/bridging.jp\/sample\/sample.incrom.com\/en\/wp-json\/wp\/v2\/tags?post=156"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}