Define techno-human convergence.
CRO & clinical capabilities
Full-service Clinical Research Organization (CRO) and Site Management Organization (SMO) for trials at the meeting of living systems and engineered systems: biologics, devices, and cognitive interventions.
NCT07214974 — Mild Cognitive Impairment Community Screening and Early Intervention via Regenerative Therapy and Wearable Brain-Computer Interface Device
1. Executive summary
WeMake, Corp. is an innovative technology company engaged with the convergence of carbon-based and silicon-based life, and of human and artificial intelligence. Our clinical research practice turns that thesis into trial execution: biotherapeutics, neuromodulation, and AI-enabled study operations. We provide comprehensive CRO and 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 empowers clinical research through technology-driven partnerships across biotherapeutics, neuromodulation, and AI. 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
- Average team experience: 8+ years per member.
- Studies delivered: 700+ across therapeutic areas, including neuropsychiatry, neurology, psychiatry, and biologic/device combinations.
- Core capabilities: Clinical data management (CRF design, database build, edit checks, query resolution, UAT, database lock); statistical programming (SDTM/ADaM, TLF, Define.xml, cSDRG); biostatistics (SAP, randomization, sample size, protocol support); medical writing; data visualization; regulatory affairs & operations.
- EDC expertise: Medidata Rave, Veeva Vault, InForm, Octalsoft, Medrio, ClinCapture, iMednet, VieDoc, Oracle, Clinform. ClinCapture Captivate® EDC on Private Clinical Cloud®—FDA 21 CFR Part 11, HIPAA, GDPR, and Annex 11 aligned.
- Global submissions: 100+ submissions to US FDA (53.7%), MHRA (7.14%), EMA (17.86%), CDSCO (10.71%), and PMDA (10.71%).
- Specialized focus: MCI and Parkinson-related populations; cognitive/neurological rating scales (e.g., MoCA, PANSS, MDS-UPDRS); biologic handling; BCI device integration; AI-driven analytics. Sites have completed multiple sponsor and CRO audits with no critical findings.
3. Services offered
Full suite of clinical research services aligned with GCP, ICH, FDA standards, 21 CFR Parts 50/54/56/312, and HIPAA.
- Regulatory & start-up: IND/IDE readiness, FDA pre-IND writing, pre-submission planning, IRB/IEC submissions, protocol development, informed consent, investigator brochures, risk mitigation.
- Site management & oversight: 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 clinics, databases (>250 patients), partnerships, digital campaigns. Projected rate: 5–20 participants/month. Education, stipends, travel support, and re-engagement for multi-year follow-up.
- Study conduct: Screening/baseline assessments (MoCA, neuropsychological batteries), intervention administration, biological sample processing, safety labs, eCRF entries, query resolution, SAE reporting (within 24 hours).
- Data management & quality: DMP, eCRF design/annotation (CDISC-aligned), eCCG, database build/UAT, data cleaning, external data reconciliation, SAE reconciliation, RBM, wearable BCI data integration, database lock.
- Project management: Dedicated manager, functional leads, KPI dashboards, weekly updates.
- FDA review & submission strategy: Briefing packages, pre-submission meetings, SAP, endpoint documentation, advisory meeting support.
- Close-out: IP reconciliation, database lock, archiving per FDA/ICH-GCP.
4. Sites and infrastructure
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 CRUs with exam rooms, private cognitive testing rooms, BCI training spaces, monitored inpatient rooms; secure pharmacy (ambient to −80°C); on-site lab (ECG, centrifuge, sample processing); emergency equipment; 24-hour temperature monitoring; local lab and radiology partnerships.
- Site capabilities: Multidisciplinary specialists (family medicine, neurology, psychiatry, geriatrics); on-site emergency response; inpatient monitoring for biologic infusions.
5. Timelines and milestones
| Milestone | Estimated timeline |
|---|---|
| Feasibility & contracting / regulatory package | 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 |
| Database lock & final report | Within 4–6 weeks post last follow-up visit |
Monthly progress reports with recruitment and retention metrics. Project management milestones from SIV through 85% enrollment to database lock.
6. FDA and IRB readiness
- Regulatory rigor: ICH-GCP E6(R2/R3), current SOPs, GCP certificates, FDA inspection readiness; rapid query turnaround (24–48 hours).
- Data integrity: Real-time verification, AE/SAE documentation (24 hours), protocol deviation tracking, CAPA plans.
- Safety: On-site emergency equipment; observation for infusions.
- QA audits: At activation, quarterly, pre-closeout; staff training/certification (delegation logs, CVs, licenses).
7. Resource framework
- 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
Dedicated teams for biologic and BCI handling, with scalability based on protocol.
8. Pricing
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.