With decades of experience across various organizations, the team at ClinDatrix possesses exceptional expertise in executing clinical trials across all phases (I-III). Our research encompasses critical studies on diabetic macular edema, meibomian gland dysfunction related to dry eye disease, open-angle glaucoma or ocular hypertension, and strategies for vision enhancement. Additionally, we investigated the effectiveness of astigmatism soft contact lenses used daily, age-related macular degeneration, vitreomacular adhesion, and the application of soft contact lenses for seven-day extended wear.
We excel in designing electronic data capture (EDC) databases tailored to complex protocols associated with these ophthalmic diseases. Our extensive experience in crafting electronic case report forms, refining protocols, and managing clinical trial logistics makes ClinDatrix well-prepared to take on your next ophthalmology clinical research project.
Key Highlights of ClinDatrix Ophthalmology Expertise:
- Agility in Study Management: We can launch study databases on our own servers within 5 weeks—well ahead of the industry standard of 12 weeks—and implement protocol modifications within 1-2 days rather than weeks.
- Experienced Team: ClinDatrix’s ophthalmology teams have an average of 20 years of experience, ensuring top-tier execution and strategic oversight throughout every phase of clinical trials.
- Regulatory Expertise: Our strong track record demonstrates our commitment to compliance with industry standards and regulatory requirements, ensuring adherence throughout the entire study process.
ClinDatrix provides comprehensive support to guarantee that sponsors meet their study goals with precision. Our dedication to operational excellence and scientific integrity underpins this.
Contact ClinDatrix today to learn more about how our ophthalmology study services can enhance your research projects.
ClinDatrix Ophthalmology Studies:
Service Codes
- BI = Biostatistics
- CL = Clinical
- DM = Data Management
- FS = Full Service
- MS = Medical Safety
- MW = Medical Writing
- RA = Regulatory Affairs
| Phase | Indication | Services | Number of Sites | Number of Patients |
|---|---|---|---|---|
| 2 | Diabetic Macular Edema | BI, CL, DM, MW | 8 | 40 |
| 2 | Meibomian Gland Dysfunction Associated Dry Eye Disease | BI, CL, DM, MW | 5 | 90 |
| 2 | Dry Eye | BI, DM | 2 | 62 |
| 1/2 | Open-angle Glaucoma or Ocular Hypertension | BI, CL, DM, MS, MW | 1 | 50 (18) |
| Medical Device Feasibility Study | Vision Improvement | FS | 22 | 396 |
| Medical Device Crossover Study | Vision Improvement | FS | 11 | 198 |
| For Approval | Astigmatism Soft Contact Lenses worn on a Daily Basis | FS | 2 | 120 |
| 1 | Diabetic Macular Edema | BI, CL, DM | 6 | 22 |
| 1 | Age-Related Macular Degeneration | DM | 8 | 56 |
| N/A | Dry AMD | DM, MS | 2 | 15 |
| Medical Device PMA | Soft Contact Lenses worn on a 7-Day Extended Wear | FS | 34 | 818 |