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Leads: COO |
Co-Lead: Head of Clinical and Project Management |
Opsidio will use Veristat (formerly Catalyst) for regulatory operations and filing and maintenance of the IND. Veristat will also assist with the writing of some of the IND modules. Please see the attached proposals for detail of services to be provided. A pre-IND meeting is planned in approximately month 11. Documents... |
The Head of Clinical and Project Management will lead an IND team to manage the delivery and content of the IND submission. This team will have responsibility to prepare all IND modules and documents, in coordination with Selexis, KBI Biopharma, BDO and CRL. For regulatory strategy we will use Mark Ammann, Pharm D., SV... |
The pre-IND package will include a concise pharmacologic rationale, a description of the CMC and GLP toxicology programs, and detailed protocol synopsis of the SAD/MAD Phase I/IA Trial study in HV and the PoC Phase I/IB Trial in AD subjects clinical studies, including a description of the planned PD markers in the usua... |
Key dependencies of IND: |
• Modules are dependent on timely reports from CMC, CLD and Toxicology |
• Critical path to IND submission timing are the draft GLP toxicology report and Fill Finish |
Objectives: |
• Timely and informative pre-IND meeting |
• Timely submission and acceptance of IND to support first in human study |
IND Subteam: |
[IND Subteam organizational chart] |
Clinical |
Leads: Head of Clinical and Project Management |
Co-Lead: CEO |
The Head of Clinical, supported by the CEO, will work with the vendors to ensure quality and efficiency in study execution, assay performance, drug supply and data reporting. Two studies are planned: a SAD/MAD Phase I/IA Trial in healthy volunteers and a Phase I/IB Trial in Atopic Dermatitis patients. The agreed-upon c... |
GCP compliance will be inherent in each trial design, and the conduct will be fully ICH-compliant. Compliance begins with the CRO-based quality control procedures. In addition, sponsor quality oversight is essential. After a qualification audit by QA, a contract will be executed including a formal Transfer of Regulator... |
Both the Phase I/IA Trial and Phase I/IB Trial will have Data Monitoring Committees primarily to evaluate ongoing safety. The DMC will consist of The CRO Study Director, an independent statistician, one or more internists experienced in phase 1 studies, and for the Phase I/IB Trial, the Principal Investigator. As these... |
Key dependencies for clinical: |
• IND open |
• Clinical Supply |
Objectives: |
• Completion of a SAD/MAD Phase I/IA Trial in HV demonstrating suitable safety, PK and tolerability for clinical use in patients |
• Completion of Phase I/IB Trial in AD patients to demonstrate PK, safety, tolerability and preliminary efficacy |
o Identify recommended Phase II Trial and Phase III Trial dose |
o Identify exploratory biomarkers for association with clinical response |
Clinical Development Subteam: |
[Clinical Development Subteam organizational chart] |
Project Management |
Lead: Head of Clinical and Project Management |
Co-Lead: COO |
Objective: |
• To develop procedures of initiation, planning, communication, execution and monitoring of project activities, ensuring risks are identified and addressed to ensure program success |
• The successful guidance of the project team's operations towards achieving all the agreed upon goals within the set scope, time, quality and budget standards. |
Opsidio will use project management methodology for all functions based on strategic program management, risk management, and standard progress reporting to facilitate oversight of the clinical programs. |
A program management plan will be developed by Opsidio and agreed by stakeholders ensuring alignment on critical path deliverables, success criteria, and associated timing. The plan will integrate cross-functional delivery and assure alignment between individual functional groups and various outsourced providers, and w... |
As part of ongoing clinical program management, Opsidio project management will be responsible for tracking for each study the functional assignment and key milestone targets/ actuals on a study scope and milestone tracker. Study core metrics will also be compiled summarizing KPIs of actual to target for core trial ope... |
A study risk management log will be maintained for each study, proactively identifying potential issues, probability and impact, and preventive and reactive actions to be taken. These logs will be maintained by Opsidio but also utilized to document sponsor oversight and escalation of issues with vendors. Contingency pl... |
The study scope and milestone target reports, core key performance indicators and metrics, and risk management logs will be summarized monthly and provided to AbbVie, similar to other functional areas, as part of an executive summary of program progress. Following are sample reports. |
Study Scope and Milestone Targets |
Protocol |
Indication/ Patient Population |
Dose |
# Total Sites |
# Total Patients |
Country Names (list all known) |
Phase |
Lead |
Function |
Project Management |
Regulatory |
Monitoring |
Document Management (eTMF) |
Data Management |
EDC (vendor or platform) |
IVRS/ IWRS |
Central Lab |
PK |
Safety / PV |
Drug Distribution |
Statistical Analysis |
Medical Writing |
Central Reading |
Milestone Target |
Final Protocol |
First Patient In |
Last Patient In |
Last Patient Out (final visit primary analysis) |
Clinical Database Lock |
Topline Primary Results |
Primary Final Tables, Figures and Listings |
CSR |
Last Patient out (follow-up) |
Final Closeout Addendum/ CSR |
KPI-Study Core Metrics |
Protocol |
Indication |
Country Names |
Phase |
Clinical Lead |
Regulatory Lead |
Metric |
Final Protocol |
Active Enrollment |
Open but Closed to Further Enrollment |
# Active Sites Planned Total |
# Active Sites Selected Total |
# Active Sites Activated Total |
# Activated Sites Change this week |
# Actives Site Actual to Target (+/-) |
# Enrolled Subjects Planned Total |
# Enrolled/Randomized Subjects Actual Total |
# Enrolled Subjects Change this week |
# Subjects Currently in screening (consented) |
# Enrolled Subjects Actual to Target (+/-) |
Other Achieved Milestones/ Progress |
Next Milestone |
Study Risk Management |
FUNCTIONAL AREA |
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