Choosing an ophthalmology clinical trial endpoint services partner can be a labor-intensive and lengthy process. Do you ever wonder if you’re asking the right questions in your selection process? We have provided some key questions below that will help you vet prospective ophthalmology partners.
- What is the company’s ophthalmology experience and expertise? Specifically:
- How many imaging studies (in our indications of interest) have you completed? While this may be an obvious question, every specialty ophthalmology service provider offers a knowledge base for your study, but not all have the same breadth and depth of experience.
- Do you have experienced ophthalmologists available to ensure consistent data review and interpretation? Will an expert be available to answer your protocol-related questions?
- What reading services do you provide? In addition to Color FP, OCT, FAF, and FA/ICGA, do you also offer microperimetry, electroretinogram, and specular microscopy? Even if your current study doesn’t require the less common modalities, consider your future studies, as ideally the partner you select could be long-term.
- What are their operational capabilities for ophthalmic trials?
- Do you offer a full-featured imaging clinical trial data platform? It’s important that the company provides a single, fully validated, secure technology platform for the entire workflow process from image upload to analysis to export.
- Does your platform provide direct image transfer capabilities? Their operational capabilities should also include the ability to transfer DICOM images directly to your designated data warehouse, if desired.
- What reading center services and image grading capabilities do you provide? Their reading center services should be easily configured to meet your study requirements. Ideally, multi-step grading would be built into their platform, providing users the ability to adjudicate discrepant or questionable features on the image and provide a single grading result.
- Does your software have configurable data export capabilities? For example, can data exports be configured for CDISC format?
- What does the company offer in terms of innovation related to ophthalmic imaging trials?
- What are your plans for future development and new services offerings? For example, are you working on widefield retinal imaging or custom microperimetry testing? This can be another important question for the future of your potential partnership.
- Do they provide experienced, ophthalmic-specific project management support as well as training and certification for imaging sites?
- What is the average tenure of the project managers that will be working on our study? We recommend asking about both their years of experience at the company as well as their overall experience in ophthalmology clinical trials.
- Will we have backup project managers that are trained in our protocol (beyond our dedicated PM team)? This provides continuity and a seamless transition if needed.
- Does your company provide training to sites such as detailed imaging procedure manuals and software tutorials? Efficient training and certification are vital for successful studies.
- Do you have existing relationships with imaging sites that may allow for express certification? This may allow you to reduce study start up time.
- Does the company have robust Quality Assurance, data security, and data privacy protection?
- Does your company have a quality system that supports GxP, ISO, ICH, 21 CFR Part 11, software validation, and auditing standards? Are they committed to consistently meeting all applicable regulatory requirements?
- Do you maintain regulatory compliance adhering to data privacy standards for ophthalmology clinical trial data including HIPAA, GDPR, and HGRAC (at a minimum)? Is data privacy built not only into their platform but also prioritized in their company policies?
- What is your company’s experience in providing data for regulatory submissions? Confirm your clinical trial endpoint data will stand up to intense regulatory scrutiny by asking about the company’s experience with FDA and other regulatory submissions.
Every therapeutic area presents unique challenges, and ophthalmology is no exception. The right partner can deliver tailored expertise that enhances your clinical trial outcomes. If you’re looking for an ophthalmology endpoint services provider that will value your partnership and make your study a priority, consider MERIT.
BENEFITS TO PARTNERING WITH MERIT
- Transparent communication with prompt access to in-house ophthalmology experts
- Deep bench of project managers, trained in industry sponsored ophthalmic clinical trials
- Experienced and tenured staff with a dedicated team for every project
- Standard processes for all imaging site qualification, training, and certification, reducing site management burden
- EXCELSIOR™, our cloud-based software solution, is designed for imaging studies and is FDA 510(K) approved and HIPAA, 21 CFR Part 11, and GDPR compliant
- Proven track record supporting FDA approval of numerous products
- Experienced and trusted R&D partner
We understand the drug discovery process is complex and demanding, and the clinical stage is resource-intensive and high-risk. With over 260 hosted trials, MERIT has the proven experience to help you accelerate your product development. Our specialized ophthalmology expertise informs every facet of our relationship with you, making our partnerships simpler and more efficient.
Connect with us to learn more about how our expertise and approach can support bringing your product to market on-time and on-budget.