1. Executive Summary

WeMake, Corp. is a technology-oriented strategic consulting firm with deep expertise in biotherapeutics, neuromodulation, AI integration, and advanced robotics. Our clinical research practice extends this foundation to comprehensive CRO and Site Management Organization (SMO) capabilities, with over 150 studies managed, 200+ collaborating sites, and a focus on patient-driven excellence. We ensure timely execution, regulatory compliance, and seamless FDA review for multi-arm trials involving biologics, devices, and cognitive interventions, including FDA pre-IND application writing services.

With a network of sites accessing diverse populations (including 16,000+ adult patients and databases of >250 aging individuals), we specialize in neuropsychiatric trials such as Mild Cognitive Impairment (MCI). Our integrated solutions cover regulatory support, site management, patient recruitment, data management, and long-term follow-up, leveraging AI-enhanced tools for data visualization and real-time insights. We are committed to high-quality, secure, and scalable clinical data solutions, with a track record of 700+ studies delivered globally.

2. Company Overview and Expertise

WeMake, Corp. empowers clinical research success through technology-driven partnerships, focusing on high-quality, secure, and scalable solutions across biotherapeutics, neuromodulation, AI, and robotics. Our clinical research division provides end-to-end services, with combined team experience exceeding 120+ years from subject matter experts (SMEs) and 75+ years from founders in clinical development.

Key Qualifications and Experience:

• Average Team Experience: 8+ years per member.
• Studies Delivered: 700+ across therapeutic areas, including neuropsychiatry, neurology, psychiatry, and biologic/device combinations.
• Expertise in Key Areas: 60% of our team are experts in end-to-end project execution, including:
  • Clinical Data Management: CRF design, database build, edit check programming, query resolution, UAT cycles, database lock.
  • Statistical Programming: SDTM/ADaM programming, TLF generation, Define.xml and cSDRG creation, regulatory submission deliverables.
  • Biostatistics: SAP creation, randomization, mock shells, sample size calculation, protocol design support, regulatory inputs.
  • Medical Writing, Data Visualization, Regulatory Affairs & Operations.
• EDC Expertise: Vast experience across platforms like Medidata Rave, Veeva Vault, InForm, Octalsoft, Medrio, ClinCapture, iMednet, VieDoc, Oracle, and Clinform. We utilize ClinCapture's Captivate® EDC for seamless data capture on a Private Clinical Cloud® platform, ensuring FDA 21 CFR Part 11, HIPAA, GDPR, and Annex 11 compliance.
• Global Regulatory Submission Success: 100+ submissions to US FDA (53.7%), MHRA (7.14%), EMA (17.86%), CDSCO (10.71%), and PMDA (10.71%).
• Specialized Focus: Extensive experience in MCI and Parkinson-related populations, cognitive/neurological rating scales (e.g., MoCA, PANSS, MDS-UPDRS), biologic handling, BCI device integration, and AI-driven data analytics. Our sites have successfully completed multiple sponsor and CRO audits with no critical findings.

3. Services Offered

We provide a full suite of clinical research services tailored for studies like NCT07214974, ensuring compliance with GCP, ICH, FDA standards, 21 CFR Parts 50/54/56/312, and HIPAA.

Scope of Work:

• Regulatory & Start-Up: IND/IDE readiness, FDA pre-IND application writing service, FDA pre-submission planning, IRB/IEC submissions, protocol development, informed consent, investigator brochures, risk mitigation.
• Site Management & Oversight: National network of 200+ sites, budget/contract negotiation, on-site/remote monitoring, protocol training, compliance oversight.
• Patient Recruitment & Retention: Community-based recruitment for adults ≥55 (MCI suspected/confirmed) via internal clinics, databases (>250 patients), partnerships, digital campaigns. Projected rate: 5–20 participants/month. Patient education, stipends ($89/visit), travel ($60/visit), and re-engagement to minimize dropouts over 5-year follow-ups.
• Study Conduct: Screening/baseline assessments (MoCA, neuropsychological batteries), intervention administration (wellness, BCI, biologic/placebo), biological sample processing, safety labs, eCRF entries, query resolution, SAE reporting (within 24 hours).
• Data Management & Quality: Development of Data Management Plan (DMP), eCRF design/annotation (CDISC-aligned), eCRF Completion Guidelines (eCCG), database build/UAT, data cleaning, external data reconciliation (labs, ECG), SAE reconciliation, query management, monthly reports, database lock. Real-time source-to-EDC verification, audit trails, Risk-Based Monitoring (RBM). Integration of wearable BCI data.
• Project Management: Dedicated manager, functional leads, centralized platforms for tracking, KPI dashboards, weekly updates.
• FDA Review & Submission Strategy: Briefing packages, pre-submission meetings, Statistical Analysis Plan (SAP), endpoint documentation, advisory meeting support.
• Close-Out: IP reconciliation, database lock, archiving per FDA/ICH-GCP.

4. Hospital & Clinic Sites and Infrastructure

Our network includes independent research sites strategically associated with large medical networks:

• Patient Access: 16,000+ adult patients, diverse aging populations ideal for MCI studies. Databases of >250 patients aged 55+ under psychiatric/neurological care.
• Facilities:
  • Dedicated Clinical Research Units with 4 exam rooms, private cognitive testing rooms, BCI training spaces, 4-bed monitored inpatient rooms.
  • Secure pharmacy: Ambient, refrigerated, -20°C/-70°C/-80°C storage, restricted access.
  • On-site lab: ECG, centrifuge, sample processing, dry ice access, secure data systems (21 CFR Part 11 compliant).
  • Emergency: Fully equipped crash cart, AED, oxygen, nursing support; hospital <5 minutes away.
  • Temperature-controlled rooms/freezers with 24-hour monitoring/loggers.
  • Local lab partnerships, radiological diagnostics (same-day access).
• Site Capabilities: Multidisciplinary specialists (family medicine, neurology, psychiatry, geriatrics), on-site emergency response, inpatient monitoring for biologic infusions.

5. Timelines and Milestones

Our timelines are flexible and adaptable to project urgency.

Milestone	Estimated Timeline
Feasibility & Contracting/Regulatory Package Submission	2–4 weeks
IRB/IEC Submission & Approval	2–4 weeks post-contract
Site Initiation Visit (SIV)	Within 1 week post-IRB
First Patient In (FPI)	Within 1 week post-SIV
Enrollment Ramp-Up	6 weeks to steady rate
Expected Enrollment Rate	5–20 subjects/month
Last Patient In (LPI)	Based on global timeline
Follow-Up Completion	As per protocol (up to 5 years)
Database Lock & Final Report	Post-follow-up; within 4–6 weeks post-FPV

Project Management Milestones:

• Milestone 1: SIV completed/site activated.
• Milestone 2: First patient screened/randomized.
• Milestone 3: First 15–20 patients enrolled.
• Milestone 4: 85% enrollment completion.
• Milestone 5: Database lock/final report.

Monthly progress reports with recruitment/retention metrics.

6. Strategies for Smooth FDA and IRB Review

• Regulatory Rigor: Full compliance with ICH-GCP E6(R2/R3), up-to-date SOPs, GCP certificates, FDA inspection readiness. Internal pre-review of consents/documents, rapid query turnaround (24–48 hours).
• Data Integrity: Real-time verification, AE/SAE documentation/reporting (24 hours), protocol deviation tracking, CAPA plans.
• Safety Enhancements: On-site emergency equipment, observation for infusions.
• QA Audits: At activation, quarterly, pre-closeout. Staff training/certification (delegation logs, CVs, licenses).
• Support: Assistance with interim updates, annual reports, combination product strategies.

7. Resource Requirements

• Staffing:
  • 1 Principal Investigator (e.g., Board-Certified Neurologist/Psychiatrist).
  • 1–2 Sub-Investigators.
  • 4 Clinical Research Coordinators (MoCA/PANSS/MDS-UPDRS trained).
  • 1–2 Raters, 1 Regulatory Specialist, 1 Recruitment Coordinator, 1 Lab Technician, Pharmacy Support.
• Capacities: Dedicated teams for biologic/BCI handling, with scalability based on protocol.

8. Pricing and Budget Framework

Our pricing aligns with fair-market value for early-phase interventional studies, using a milestone-based fixed-fee model or per-hour/per-day rates. Detailed budgets are prepared upon protocol receipt and shared under confidentiality.

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