Synchrogenix Information Strategies Inc.
What Synchrogenix Offers Largest regulatory and medical writing company 23 years of experience  Expertise in supporting gl...
Synchrogenix focuses on the writing component  to support drug approval and commercialization.  We collaborate with our cl...
Synchrogenix Locations North American Locations: Wilmington, Del. Malvern, Penn. Boston, Mass. European Location: High Wyc...
Synchrogenix Methodology <ul><li>Content Management </li></ul><ul><ul><li>Employ a common approach, ensuring that document...
Synchrogenix Talent  <ul><li>Experience </li></ul><ul><ul><li>Writers’ backgrounds include work in large pharmaceutical an...
Security & Confidentiality <ul><li>Cryptographic Controls </li></ul><ul><ul><li>Cisco VPN technologies </li></ul></ul><ul>...
Drug Approval—Regulatory Writing Spanning the product lifecycle for standardized regulatory submissions <ul><li>Document d...
Years 1 16 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Early Phase Activity  IND CTA Filing  NDA/MAA  Licence Application Drug Disco...
Preclinical & Clinical <ul><li>INDs/IMPD </li></ul><ul><li>Clinical Development Plans </li></ul><ul><li>Notebooks </li></u...
Drug Safety & Pharmacovigilance <ul><li>Retrospective Literature Search </li></ul><ul><li>Preliminary Benefit Risk Assessm...
CMC:  Chemistry, Manufacturing, & Controls <ul><li>IND </li></ul><ul><li>Process </li></ul><ul><li>Development </li></ul><...
Regulatory Operations & Project Management <ul><li>Document Lifecycle Management </li></ul><ul><li>Version Control Protoco...
Synchrogenix Delivers World-Class Performance in Medical Writing Synchrogenix Traditional  CRO  Players Traditional BPO Pl...
Why Synchrogenix? <ul><li>Quality  </li></ul><ul><ul><li>Global best practices and experience </li></ul></ul><ul><ul><li>P...
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Synchrogenix Inc Capabilities Presentation Jan 2010 Final

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Capabilities presentation of Synchrogenix Inc. a medical, technical and scientific writing company.

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Synchrogenix Inc Capabilities Presentation Jan 2010 Final

  1. 1. Synchrogenix Information Strategies Inc.
  2. 2. What Synchrogenix Offers Largest regulatory and medical writing company 23 years of experience Expertise in supporting global pharmaceutical and biotech companies Significant small and large molecule experience Scalable solutions Writers who are all permanent employees (no contractors) Complete outsourcing capability
  3. 3. Synchrogenix focuses on the writing component to support drug approval and commercialization. We collaborate with our clients to develop the key messaging for each document type. Medical Writing Regulatory Submissions MD Education Marketing Publications
  4. 4. Synchrogenix Locations North American Locations: Wilmington, Del. Malvern, Penn. Boston, Mass. European Location: High Wycombe, Buckinghamshire Asia Pacific Location: Manila, Philippines
  5. 5. Synchrogenix Methodology <ul><li>Content Management </li></ul><ul><ul><li>Employ a common approach, ensuring that documents can be transferred among regions. </li></ul></ul><ul><li>Team Centric </li></ul><ul><ul><li>Effective communication within Synchrogenix ensures continuity of project information, and our rigorous internal quality control process delivers consistently excellent results. </li></ul></ul><ul><li>Complementing Skill Set </li></ul><ul><ul><li>Assign staff with the appropriate experience to complete the specific task in a cost-effective manner. </li></ul></ul>
  6. 6. Synchrogenix Talent <ul><li>Experience </li></ul><ul><ul><li>Writers’ backgrounds include work in large pharmaceutical and biotechnology companies, CROs, and academia </li></ul></ul><ul><li>Functions </li></ul><ul><ul><li>Writers with 20+ years of regulatory, clinical, and preclinical experience </li></ul></ul><ul><li>Therapeutic areas </li></ul><ul><ul><li>Autoimmune, allergy, CNS, cardiovascular, dermatology, GI, hematology, immunology, infection, oncology, pain, respiratory, and virology </li></ul></ul>
  7. 7. Security & Confidentiality <ul><li>Cryptographic Controls </li></ul><ul><ul><li>Cisco VPN technologies </li></ul></ul><ul><ul><li>Encrypted email tunnels between Synchrogenix and clients (TLS)  </li></ul></ul><ul><ul><li>1024-bit RSA public key & 128-256-bit private key SSL Certificates </li></ul></ul><ul><li>CFR Part 11 Compliance </li></ul><ul><ul><li>All systems and controls constructed and managed for CFR Part 11 compliance </li></ul></ul><ul><li>Virus Scanning and Security Patches </li></ul><ul><ul><li>All emails and computing devices scanned for viruses </li></ul></ul><ul><ul><li>Virus definitions updated daily </li></ul></ul><ul><ul><li>All computing devices updated with latest security patches weekly  </li></ul></ul>
  8. 8. Drug Approval—Regulatory Writing Spanning the product lifecycle for standardized regulatory submissions <ul><li>Document development </li></ul><ul><li>Data collection and interpretation </li></ul><ul><li>Document management and maintenance </li></ul><ul><li>Technical editing </li></ul><ul><li>Quality control </li></ul><ul><li>Development of product labels and patient information </li></ul><ul><li>Submission compilation </li></ul><ul><li>Project management </li></ul>
  9. 9. Years 1 16 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Early Phase Activity IND CTA Filing NDA/MAA Licence Application Drug Discovery Drug Development Target and Lead Identification Lead Optimization Concept Testing Development for Launch Launch Clinical Development Phase I 50-150 people Phase II 100-200 people Phase III 500-5,000 people Phase IV Studies Continue Product Life Cycle Support Preclinical and Clinical Writing Drug Safety & Pharmacovigilance CMC: Chemistry, Manufacturing, & Controls Regulatory Operations & Project Management The Path to New Medicine Clinical Phase I-III Post Marketing Activities Whether we work with your internal resources or your third parties, Synchrogenix can step in or out at any time or stage.
  10. 10. Preclinical & Clinical <ul><li>INDs/IMPD </li></ul><ul><li>Clinical Development Plans </li></ul><ul><li>Notebooks </li></ul><ul><li>GLP Audits </li></ul><ul><li>SOPs </li></ul><ul><li>Lab setup/ scale up </li></ul><ul><li>Study Protocols </li></ul><ul><li>CSRs </li></ul><ul><li>Investigator’s Brochures </li></ul><ul><li>Information Amendments </li></ul><ul><li>Briefing Documents </li></ul><ul><li>Annual Reports </li></ul><ul><li>Agency Responses </li></ul><ul><li>NDA/BLA/ ANDAs/MAA </li></ul><ul><ul><li>Summary Documents </li></ul></ul><ul><ul><li>Modules 2, 4, and 5 </li></ul></ul><ul><li>CSRs </li></ul><ul><li>Narratives </li></ul><ul><li>CSRs </li></ul><ul><li>Narratives </li></ul><ul><li>Label Extension </li></ul><ul><li>Document Maintenance </li></ul>Define Pharmacology & Toxicology Confirmation of Safety Profile Confirmation of Efficacy in Target Populations Pooled Data Analysis Monitor & Evaluate
  11. 11. Drug Safety & Pharmacovigilance <ul><li>Retrospective Literature Search </li></ul><ul><li>Preliminary Benefit Risk Assessment </li></ul><ul><li>Market/Exposure Assessment </li></ul><ul><li>Signal Detection </li></ul><ul><ul><li>Monthly monitoring </li></ul></ul><ul><ul><li>Case series analysis </li></ul></ul><ul><ul><li>Pre-aggregate report documents </li></ul></ul><ul><li>Labeling Modification </li></ul><ul><ul><li>Case series analysis </li></ul></ul><ul><ul><li>Discussion documents </li></ul></ul><ul><li>RM Plan </li></ul><ul><li>RiskMAP </li></ul><ul><li>Aggregate Reports </li></ul><ul><ul><li>Periodic Review </li></ul></ul><ul><ul><li>PSUR </li></ul></ul><ul><ul><li>DSUR </li></ul></ul><ul><ul><li>Ad hoc response documents </li></ul></ul><ul><li>Pharmaco-epidemiology studies </li></ul>Build Safety Risk Awareness Identify Safety Risk Issues & Develop Options Monitor & Evaluate
  12. 12. CMC: Chemistry, Manufacturing, & Controls <ul><li>IND </li></ul><ul><li>Process </li></ul><ul><li>Development </li></ul><ul><li>Plan </li></ul><ul><li>Process Validation </li></ul><ul><li>Reports </li></ul><ul><li>Alternate Vendor </li></ul><ul><li>Qualification Reports </li></ul><ul><li>Final Specification </li></ul><ul><li>Reports </li></ul><ul><li>Summary </li></ul><ul><li>Documents </li></ul><ul><li>Modules 2 & 3 </li></ul><ul><li>Stability Studies </li></ul><ul><li>Protocol </li></ul><ul><li>RM/Product </li></ul><ul><li>Validation Reports </li></ul><ul><li>Purification </li></ul><ul><li>Studies </li></ul><ul><li>Product </li></ul><ul><li>Characterization </li></ul><ul><li>Studies </li></ul><ul><li>Label & Package </li></ul><ul><li>Review </li></ul><ul><li>Commercial </li></ul><ul><li>Transfer </li></ul><ul><li>Documents </li></ul><ul><li>CBE </li></ul><ul><li>PAS </li></ul><ul><li>SUPAC </li></ul><ul><li>Document </li></ul><ul><li>Maintenance </li></ul>Formulation & Process Development Tech Transfer Validation Data Integration Monitor
  13. 13. Regulatory Operations & Project Management <ul><li>Document Lifecycle Management </li></ul><ul><li>Version Control Protocol </li></ul><ul><li>Security Protocol </li></ul><ul><li>Document Formatting </li></ul><ul><li>Editing </li></ul><ul><li>Quality Control </li></ul><ul><li>Appendix Compilation </li></ul><ul><li>Modules 1 through 5 </li></ul><ul><li>CTD/eCTD Formation </li></ul><ul><li>Final Document Delivery </li></ul><ul><li>Editing </li></ul><ul><li>Quality Control </li></ul><ul><li>Document Level Publishing </li></ul><ul><li>ISI Toolbox </li></ul><ul><li>Bookmarked and Internally Linked Document for Submission </li></ul><ul><li>Style Guide Development </li></ul><ul><li>Template Creation </li></ul><ul><li>CTD/eCTD File Backbone & Granularity Definition </li></ul><ul><li>ICH Compliance </li></ul><ul><li>SOP Development </li></ul><ul><li>Conformance Guide </li></ul><ul><li>Electronic Library </li></ul><ul><li>Annual Reports & Updates </li></ul>Template & Process Design Document Management Publish Maintain
  14. 14. Synchrogenix Delivers World-Class Performance in Medical Writing Synchrogenix Traditional CRO Players Traditional BPO Players Scope of expertise Depth of expertise in medical writing High Medium Low Knowledge of global regulations and guidances High Medium/High Low Therapeutic expertise High High Low Document services and management High Medium Medium Data interpretation High High Medium Quality Quality control and assurance High Medium Medium/Low Communication High Medium/High Medium Cost Cost savings Medium/High Low High Operational Process integrity High Medium High
  15. 15. Why Synchrogenix? <ul><li>Quality </li></ul><ul><ul><li>Global best practices and experience </li></ul></ul><ul><ul><li>Processes and safeguards to mitigate risk </li></ul></ul><ul><ul><li>Customer service </li></ul></ul><ul><li>Speed </li></ul><ul><ul><li>24/7 operation </li></ul></ul><ul><ul><li>Flexible, scalable solutions </li></ul></ul><ul><ul><li>Deadline driven </li></ul></ul><ul><li>Efficiency </li></ul><ul><ul><li>Collaboration and integration </li></ul></ul><ul><ul><li>Off-shore capability </li></ul></ul><ul><ul><li>Project management </li></ul></ul>

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