We develop and execute a clinical study plan that meets your study timeline & goals.
The role of Project Manager is crucial for the success of any clinical study. Sierra PMs are prepared to adapt to the ever-changing landscape of the clinical trial environment. We are prepared to immerse into your project and seamlessly become part of your team.
To ensure operational excellence, our team of well-respected Project Managers is comprised of highly skilled, experienced, accountable, motivated individuals. Our team ensures your clinical trial is carefully planned from the start in an extremely detailed manner utilizing study planning tools developed over many years of trial experience.
Our attentive experts will oversee enrollment, manage IRB submissions and approvals, manage CRAs and monitoring progress, track safety events and protocol deviations, resolve site-specific or general study issues, facilitate team meetings, manage query status, write study newsletters as well as many other routine study management activities.
We have a vast understanding and training of GCPs in accordance with regulations.
At Sierra, we have CRAs located regionally across the United States and Europe to support your study monitoring needs.
Our monitors are specialists in the unique requirements associated with medical device research. Our CRAs have 10+ years experience in Ophthalmology and on average more than 25 years of monitoring experience. They ensure sponsors and PMs are kept in the loop at all times.
Sierra believes in building strong relationships with clinical sites to ensure a site's commitment to a study. We lend a hand to site staff and coordinators by providing assistance and additional study training when needed, resolving study issues efficiently, and guiding site staff throughout the course of every trial from startup to close-out.
In-depth level monitoring while balancing precision and efficiency is our specialty. This ensures the clinical data captured represents high accuracy and completeness. 100% source document verification (SDV) is performed by comparison of subject source documents and clinic charts to data entered into the EDC system. Monitors utilize EDC tools to quickly identify records requiring SDV and queries needing resolution.
Comprehensive regulatory document review is performed routinely during visits to ensure compliance with the protocol and regulations.
Our Monitoring services include:
Our Study Support services include:
We ensure precise data management and accelerate the data capture process.
Data Management is one of the most critical functions in a clinical trial. Our team of DM experts understand the quality of a clinical trial is ultimately dependent upon the accuracy and integrity of the data captured throughout a study. At Sierra, we offer services that ensure data is managed meticulously, carefully and efficiently.
Utilizing only the best electronic cloud-based tools, Sierra’s DM team diligently oversees data quality using tools reports, dashboards and listings to aid in data cleaning and identification of outliers. We keep a close eye on not only query status, but also the frequency in which queries trigger to catch study or data issues as quickly as possible.
We ensure a well-written Data Management Plan is in effect that outlines each study’s DM requirements and procedures to be followed. Our innovative processes comply with Good Clinical Data Management Practices (GCDMP) while accelerating the overall data capture process.
Our Data Management services include:
We build EDC databases that provide data in real time. Our EDC system is a favorite among study sites and includes tools for efficient study management, custom reporting and interactive study dashboards.
At Sierra, our team of experts build EDC databases for any size study from Phase I to Phase IV and everything in between. We utilize efficient and intuitive, Part 11 compliant, validated systems. Custom real-time reporting allows sponsors to access data on-demand via browser or phone. Advanced interactive study management dashboards provide a bird’s-eye view for oversight of study status, site management, safety management and compliance with the ability to quickly drill down to the details.
We generate database design specifications (DDS) based on the study protocol and case report forms or source documents. This serves as the roadmap to the eCRF design and EDC configuration. We partner with you to discuss the details and ensure everything is reviewed and approved prior to database build.
Within the DDS specifications, our experts include detailed electronic data checks that conform to the requirements of the protocol and include checks for eligibility, expected legal ranges, completeness of eCRFs and logical consistency. Prior to programming, the client will review and approve proposed data checks.
Upon completion of the EDC build, user acceptance testing (UAT) will be performed by our experts via a series of test scenarios ensuring the database fully conforms with the DDS specifications. A final UAT report and annotated CRF document are included with the deliverables for every EDC project.
The user training module is customized for each study to include on-demand videos for users to complete prior to obtaining system access.
Our Database Development services include:
We are laser focused on subject safety during clinical trials.
At Sierra, subject safety is the primary priority during the conduct of a study. Our team of highly experienced experts ensure proper safety oversight.
We create a safety management plan (SMP) detailing requirements and procedures for the processing and reporting of serious adverse events (SAEs) during trials. The SMP provides roles, responsibilities, processes and timelines for all safety related activities.
We leverage our technology tools to facilitate the safety oversight and review processes. All safety documentation will be tracked, filed, and readily available to our sponsors.
Our Safety Management services include:
We empower our study sites and sponsors by careful audit planning & preparation to achieve positive results.
Our team has extensive experience with successfully preparing study sites and sponsors for FDA audits. Careful planning and pre-FDA audits are critical to survival of the audit process. Sierra Clinical has attended numerous FDA audits with positive results.
Our Audit services include:
Statistics & Programming
We deliver high quality statistical consulting, tables and analyses.
Our statisticians understand the critical role they play in delivering high-quality data and statistical analyses. At Sierra, our expert biostats team brings years of experience in statistics, programming and Ophthalmology. They perform data analysis for a wide range of clinical trials and will consult with you related to all your stats needs.
Our team partners with you every step of the way and provides you with required deliverables that will prepare you with the data needed for regulatory submission.
Our Statistics & Programming Services include:
We have the specialized knowledge and skills to write well-structured protocols, consents & study reports.
Our medical writing experts at Sierra are experienced in writing study documents across all phases of Ophthalmology clinical research including protocols, consents and clinical study reports (CSRs).
We understand the importance of accurately presenting study results and clearly articulating complex facts. Our team of experts deliver material that is well-written, concise and precise. All documents are produced with the utmost attention to quality and we make use of standard templates when possible.