CRO Solutions
We drive innovative projects through a close, flexible, and results-oriented approach, enabling a seamless transition from scientific development to efficient clinical execution.
Optimal Site and Investigator Selection
We identify sites and investigators with proven experience in ophthalmology, strong recruitment capabilities, and a solid track record of regulatory compliance, ensuring an efficient and sustainable study start-up.
- Analysis of previous experience in similar studies
- Review of regulatory compliance history and data quality
- Assessment of technical resources and site operational capacity.
- Strategic alignment between the investigator and project objectives
We do not simply select available sites—we partner with investigators who have demonstrated expertise in the specific pathology of each study, ensuring strong clinical knowledge and technical management aligned with the highest quality standards.
Strategic Design Tailored to Each Project
Our Project Managers lead the planning of each study, ensuring that scientific, regulatory, and budgetary objectives are aligned from the outset.
They bring extensive experience in ophthalmic clinical trials and a comprehensive view of clinical development, enabling consistent planning and effective coordination throughout the entire study lifecycle.
Strategic responsibilities:
- Act as the primary point of Contact between the client and the study team.
- Define the operational framework in terms of timelines,quality, and budget.
- Closely coordinate and oversee monitoring activities.
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Manage risks and anticipate potencial desviations
- Ensure alignment between scientific objectives and operational execution
Each project benefits from clear leadership, defined accountability, and structured decision-making.
Feasibility Assessment and Recruitment Potential
We conduct a thorough and detailed assessment of feasibility and recruitment potential at each site. Leveraging our extensive clinical experience in ophthalmology, we ensure that sites have the necessary resources to conduct the study efficiently and within established timelines.
Our approach includes:
- Historical analysis of recruitment performance in similar studies
- Evaluation of patient volume and target population profile at each site
- Strategic review of inclusion and exclusion criteria to optimize eligibility
We rely on verified data and our clinical expertise in ophthalmology to provide accurate forecasts, ensuring that the recruitment process is efficient and aligned with planned timelines.
Regulatory Management from Project Initiation
We define the regulatory strategy from the earliest stages of the project to ensure that the study is conducted in full compliance with applicable regulations, in a structured manner and aligned with quality standards.
Our approach includes:
- Preliminary analysis of regulatory requirements applicable to the study
- Definition of the submission strategy and regulatory planning
- Preparation and submission of documentation to Ethics Committees (ECs/IRBs) and competent authorities
- End-to-end management of requests, queries, and deficiency responses
- Continuous follow-up until final approval is obtained
Our approach ensures a structured and efficient regulatory process, anticipating potential issues and facilitating a smooth and timely approvals by the relevant authorities.
Monitoring (On-site and Remote)
We have a team of clinical monitors who combine experience in ophthalmic trials with in-depth knowledge of the regulatory environment, ensuring close, precise oversight with a strong focus on patient safety.
Each assigned monitor
- Conducts on-site and remote monitoring visits in accordance with the established plan
- Reviews source documentation and Case Report Forms (CRFs)
- Proactively identifies deviations and operational risks
- Maintains direct and technical communication with investigators
- Applies specialized oversight in ophthalmic studies
At Ocupharm, each study is managed by professionals with specific expertise in the relevant therapeutic area, ensuring strong clinical judgment, methodological rigor, and operational efficiency.
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