Build a Configurable Enterprise SaaS App in Only 9 Months
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This document summarizes the challenges of managing clinical trial documents and records using traditional paper-based systems and shared drives. It then describes how the company Complion developed a cloud-based configurable enterprise content management system (ECM) using MongoDB to address these challenges. Some key points: - Traditional systems resulted in high costs, security risks, storage issues, and lack of access controls for clinical trial documents. - Complion's ECM is a software-as-a-service system that allows non-technical users to configure document types, metadata fields, access controls and more on an institutional basis. - MongoDB was chosen as the database due to its ability to handle dynamic schemas through arrays, its scale capabilities
Build a Configurable Enterprise SaaS App in Only 9 Months
- 1. Lesson Learned Building a Configurable Enterprise SaaS App in 9 Months Greg Svitak CTO Complion 1 1
- 3. 33 Clinical Research Office Cube Wall
- 4. 44 Shared Drives & Email
- 6. 66 Material Costs • Correspondence (251-500+ exchanged per study) • Binders (Avg. 4+ binders per study) • Paper (Avg. 500+ pages per study) • On-site Storage (Avg. 11+ years per study) Source: CenterWatch-Complion Study, 2015; N= 164 Investigative Sites
- 7. 77 Storage Space & Long-term Costs • 3rd Party Archiving (63% per study) • Material & Archiving Cost (Avg.$1126+ per study) Source: CenterWatch-Complion Study, 2015; N= 164 Investigative Sites
- 8. 88 Security, Access & Controls • Deletion of records from shared drive • Files “walking away”, especially delegation • Physical damage to archiving facility or office • Providing access to all staff members to approved files
- 9. 99 *Average months from study startup to database lock = 24 months, estimated 255.5 hours of staff time for regulatory- related tasks per single clinical study Fair Market Value for CRC or Regulatory Specialist estimated at $50.00/hour Associated Costs % Reduction Cost Savings per Clinical Study Staff Time: $ 12,775 (40%) $ 5,110 Material: $ 1,125 (100%) $ 1,125 Total Cost Savings Per Study $ 6,235 Savings case study Source: CenterWatch-Complion Study, 2015; N= 164 Investigative Sites
- 11. 1111 Part 11 Enables Paperless Sites A site process – not a product • Software Validation on Each Update ◦ Validation SOP, Identify Requirements, Testing Protocol, Execute Test Protocol, Show Proof (Screen Shots) • Documented Policies and Procedures ◦ SOP on SOPs, Validation, Certified Copies, UAT, Vendor Audit, User Training/Identification and Linking handwritten signatures to electronic records • Audit Vendor for Their Requirements ◦ Server Installation / Operation Qualification (IQ/OQ), Network Security, Record Retention, Disaster Recovery, Backups, Internal Audits & Software Development / Validation
- 12. 1212 GCP Required Documents • Investigator Brochure • Signed Protocol & Amendments • Sample Case Report Form • Information to give to Trial Subject • Advertisements • Financial Aspects of the Trial • Insurance Statements (where required) • Signed Agreements/Contracts • IRB Dated Documented Approval • IRB Roster • Regulatory Authority Approval of Protocol • CV and Education/Training/Qualification • Lab Ranges • Medical/Lab Procedures Certification Manual • Instructions for IP and Labels • Shipping Records for IP & Trial Related Items • Certificates of IP Shipped • Decoding Procedures • Master Randomization List • Pre-Trial Monitoring List & Report • Trial Initiation Monitoring Report • Monitoring Visit Reports • Relevant Communications • Signed Informed Consents • Source Documents • Completed CRFs • AE and SAE Reports • Interim & Annual Reports • Subject Screening Logs • Subject Enrollment Logs • IP Accountability • Signature Sheets • Final Study Related Reports • Record/Retained/Shipment of Body Fluids & Tissue 53
- 13. 1313 Complion Design Principles • SAAS based Enterprise Content Management System (ECM) for clinical trials • Allow a non technical power user to point and click create configuration on an institution basis • Cloud only – multi-tenant from the beginning • 21 CFR Part 11 and HIPPAA compliant
- 14. 1414 Research Site Total Documents 1) Accounts Payable 2) Accounts Receivables 3) AE Log Template 4) Ancillary Services 5) Archived Informed Consent 6) Archived Protocol 7) Archived Sponsor/CRO Contact List 8) Audit 9) Audit Checklist 10) Audit Report 11) Audit Report Template 12) Beacon 13) Blanket Purchase Orders 14) Budget 15) Budget Tools 16) CAP 17) CDA & MTA 18) CDA Tracker 19) Certificate of Translation 20) Checklists 21) CITI Training 22) CLIA 23) Clinical Audit Checklist 24) Clinical Deviations 25) Clinical Forms 26) Completed AE Log 27) Completed Deviation Log 28) Contract 29) Coordination Forms 30) Coordinator NTF 31) Coordinator PTO Request Form 32) Counseling Certification 33) Coverage Calendar 34) CRO Recharges List 35) Cross Reference Letter 36) CRU 37) CSRC Approval Letter 38) CTO Staff Support by Disease Team 39) CTRP 40) CTSU 41) Current Informed Consent 42) Current Protocol 43) Current Sponsor/CRO Contact List 44) CVs 45) Damaged Drug Form 46) Data Submission Guidelines 47) Data Summaries 48) Delegation 49) Destruction Log 50) Deviations Requiring Action 51) Disease Team Endorsement Form 52) DMC Agenda 53) DMC Appendix 54) DMC Charter 55) DMC Letters 56) DMC Minutes 57) DMC Synopsis 58) DOA Log Template 59) DOA Profile 60) Drug Accountability Log 61) Drug Diary Template 62) Drug Orders 63) eCRF Completion Manual 64) eCRF Training Certificate 65) Eligibility Checklist 66) Eligibility Forms 67) External Audit CAPA 68) External Audit Report 69) External IRB 70) External Safety Report Attributions 71) External Safety Reports 72) FDA Communications Letter 73) FDA Cover Letter 74) FDA Form 1571 75) FDA Form 1572 76) FDA Form 3674 77) FDA Submission Authorized Contacts 78) FDA Submission Packet 79) FDA Submission TOC 80) Financial Audit Report 81) Financial Disclosure Form 82) GCP Training 83) Grant 84) Handling sheet Template 85) IATA Training Certificate 86) IB Signature Page 87) IBC Approval Letter 88) ICF Short Form 89) IIT Communication Plans with Funding Sources 90) Include Randomization?? 91) IND Annual Report 92) IND Exemption Letter 93) Institutional Authorization Agreement 94) Internal Audit Report 95) Investigators Brochure 96) IRB 97) IRB Approval Letters 98) IRB Audit CAPA 99) IRB Correspondence 100) IRB FWA 101) IRB Roster 102) IRB Submission Form 103) IVRS 104) IVRS Training Certificate 105) Lab Director CV 106) Lab Director Medical License 107) Lab Manuals 108) Lab Report 109) Lab Requisition Template 110) Letter of Intent 111) Logs 112) Master CTA 113) Medical License 114) MedWatch Safety Report 115) Moderate Intensity Monitoring Report 116) Monitoring Visit 117) NCI CIRB 118) New Protocol submission form 119) Non Clinical Deviations 120) NOTIS Training Quiz 121) NU Audit CAPA 122) NU IRB 123) Operating Account 124) Outcomes 125) Package Inserts 126) Packing List 127) Packing Slips 128) Patient & Recruitment Materials 129) Payment Tracking 130) Pharmacy CAPA 131) Pharmacy Certificates 132) Pharmacy Correspondence 133) Pharmacy Manual 134) Pharmacy Note to Files 135) PI Allocation 136) Policies 137) Procedures 138) Processing Sheet Template 139) Product ??? 140) Project Account Summaries 141) Project Account Summary Amendments 142) Protocol 143) Protocol Signature Page 144) PSV 145) Reference Ranges 146) Regulatory NTF 147) Regulatory NTF Template 148) Reimbursement Forms Blank 149) Rent Payments 150) Requisition Templates 151) Requisition 152) Research Team Meeting Minutes 153) Results Reporting 154) RNI Approval/Acknowledgment Letter 155) SAE 156) SAE Log 157) Self Financial Audits 158) Semi-Annual Reports 159) Service Contact & Request Forms 160) Shipping Slip 161) SITC Agenda Template 162) SIV Agenda Template 163) SIV Training Template 164) Slot Reservation 165) SOC v Research 166) SOP 167) Sponsor Agreement Correspondence 168) Sponsor Approval of ICF 169) Sponsor Payment Correspondence 170) Sponsor SAE Form 171) SRC 172) SRC Approval Letter 173) SRC Closure Letter 174) SRC Pending 175) SRC Progress Review Letter 176) Staff Training 177) Statistical Report 178) Study Activation Process Map - Cooperative 179) Study Activation Process Map - External IT 180) Study Activation Process Map - IIT 181) Study Activation Process Map - Sponsor 182) Study Specific Training Log 183) Template & Checklist 184) Template Email Audit Notification 185) Template ICF 186) Training Certificate Templates 187) Training Certificates 188) Weekly Tracker Template 189) WIP Financial Disclosure Form 190) WIP ICF 191) WIP of Protocol 192) WIP Protocol Writer Version 200+
- 15. 1515 Document Type • Initial level of classification • Allows user to tag the type of document • Examples • Protocol, CV, Consent, Contract
- 16. 1616 Right Person Collectively share documents with controls Ex. Reg Coordinator WIP Protocol Contract Eligibility View Download EditUpload × × × × × × ×
- 17. 1717 Metadata/ Document Attributes • Fields that users enters when uploading to allow a user to find document later. • Different fields are available for a user based on document type CV Trial(s) Lead investigator Personnel Name Expiration Date Protocol Protocol Name Eligibility criteria Effective Date Contract Trial Effective Date
- 18. 1818 Traditional Approach • Create SQL tables via admin UI • Challenges: ◦ Difficult to scale due to N number of SQL joins ◦ Number of tables due to the number of document ◦ types
- 19. 1919 Alternative Platforms • Postgres with JSON with Elasticsearch • Key value store • Native Graph • Cassandra with Datastax Search • Multi-modal db
- 20. 2020 Technical Challenge • Every document attribute can be configured to have multiple values for the same document in repository • Provides for the same document to be used multiple places in ECM repository CV Lead investigator Personnel Name Sub Investigator #1 Sub Investigator #2 Sub Investigator #n Dr Jane Harper Dr Jane Harper Dr John Doe Dr Sam Smith
- 21. 2121 Why MongoDB • Web scale • Eliminate need for separate indexing technology • Arrays … arrays… arrays – no SQL join tables • 3.2 database level enforcement of schema • Development stack alignment – Node and Python
- 22. 2222 MongoDB - Lessons learned • Dynamic schemes can be used for evil ◦ Design your schema like a traditional schema ◦ Do not just rely on application logic for enforcing schemas ◦ Segment repeating element in array very carefully • Use element match (elemmatch) for all arrays • Index the array very carefully • Keep document sizes small
- 23. 2323 Results
- 24. 2424 Results