Your clinical trial partner expert for clinical trial operations, study design, project management, clinical and medical monitoring, and site relations and training.
Lexitas understands ophthalmic clinical trials, and our goal is to deliver exceptional service to each sponsor. We understand our customer’s needs and actively build a partnership that supports the success of a well-executed trial. Our technical knowledge and expertise underpins our success in clinical trial execution. Our long-standing relationships with ophthalmic key opinion leaders and high-performing sites sets us apart. Lexitas is a strong advocate for our Sponsors with our vast network of ophthalmologists and clinical sites.
Lexitas provides the full range of clinical operations services including clinical trial management, site selection, site qualification, regulatory document collection, site management, recruitment strategy development, investigator training and other key clinical operations tasks. Our established relationships with the top-performing sites in eye care are a key differentiator of Lexitas, and effective management of clinical sites is our strength.
Clinical Study Design & Content
The Lexitas team has significant experience with ophthalmic clinical drug development and study design. We are experts in the development of clinical protocols through the review and summary of data. Our team can assist with the development of a study design incorporating regulatory strategy, site set-up, and operational and logistical considerations. Lexitas has access to industry experts and therapeutic area key opinion leaders for an integrated approach to the development of a trial plan. We work closely with our clients from the concept protocol phase through finalization of a detailed clinically and operationally feasible trial protocol.
Each project is assigned a Lexitas Study Manager who has significant experience in the management of eye care clinical trials. The Study Manager is your primary point of contact for the study. The key responsibilities of the Study Manager include communicating across all functional areas and coordinating the activities and tasks for the overall Study Team.
Communication and responsiveness is a key strength and priority for all of our Study Managers. An open style of communication is emphasized which allows for the flow of information via both formal meeting settings and also on an as needed basis.
Lexitas monitors are highly experienced, fully trained in GCP with particular expertise and a focus in Ophthalmic Drug Development. Our CRAs place a significant emphasis on developing productive relationships with their investigative sites. The monitors work closely with the Lexitas Study Manager to develop site-specific recruitment plans and to proactively communicate site performance. We encourage and empower our CRAs to take ownership for the performance of their clinical sites. Lexitas has CRAs that are full-time employees based in our home office in Durham, NC, as well as regionally based monitors and a pool of highly seasoned contract monitors. This approach allows us to monitor throughout the US and to resource our projects in an efficient and cost-effective manner.
In addition to excellent site management, our monitors are ophthalmic therapeutic area content experts. This experience enables efficient and high quality review of on-site data and monitoring of site operations. To enhance the therapeutic area knowledge base, our CRAs are required to participate in ongoing ophthalmology-specific training to stay informed of current information and trends.
Lexitas provides medical monitoring services with the input of our Chief Medical Officer and medical consultants who are each highly respected ophthalmic medical experts experienced in clinical trials. The medical monitoring service encompasses protocol development consulting, clinical study team support as well as pharmacovigilance activities (e.g., review of safety narratives, consultation regarding the assessment of reportability for safety events and follow-up on serious adverse events with investigators and sponsors). The medical monitor will also review safety documentation templates and annual safety reports as well as consult with sites as needed on evaluation of subject eligibility.
Site Relations and Training
The Lexitas team has developed strong relationships with high-performing clinical study sites and can identify and establish the suitability of study Investigators and their staffs. Lexitas will be the liaison to the site to ensure compliance with all necessary study requirements, approvals and agreements. Initiating, training, monitoring and closeout of investigational study sites will be conducted by Lexitas in accordance with company SOPs, GCP and other requirements.
Lexitas has significant experience in investigator site audits. Lexitas will assist in preparing sites are for any FDA inspection. As an independent CRO, we can objectively evaluate both sites and monitors to ensure the trial is being conducted according to the protocol, GCP, and regulatory requirements. Lexitas’ expertise in ophthalmology allows auditors to evaluate a study not simply based on processes, but actual data collection and specific ophthalmic procedures.
The Lexitas team provides the full range of data management services so that your data will be of the highest quality and your clinical trial will lock on time. Our clinical data professionals will configure and validate a database in order to collect study endpoints and supportive data, draft and finalize data entry guidelines and data management plans, perform medical coding, reconcile serious adverse events, and create a robust system of edit checks to ensure that the data are clean, consistent, and ready for statistical analysis. For randomized trials, our team can develop subject- and kit-level randomization schemes to support study masking and the packaging and labeling of study materials. Our data management services are conducted in IBM Clinical Development, meeting 21 CFR Part 11 requirements.
Biostatistics and Statistical Programming
The Lexitas team has extensive experience in the design, analysis, reporting, and interpretation of clinical trial data. Our biostatisticians have up-to-date knowledge of industry and academic developments in biostatistical methodology and regulatory trends, and they can assist sponsors in designing a trial that appropriately manages type I error across multiple primary endpoints or treatment arms. Further, biostatisticians can author statistical analysis plans and the statistical section of protocols, and elucidate analysis findings for clinical study reports. Our statistical programmers are experts in CDISC data standards and will ensure that statistical deliverables (tables, figures, and listings) and study datasets are fully documented and of the highest quality, meeting the requirements of both sponsors and regulatory agencies. In keeping with 21 CFR Part 11, we perform all development work on a fully qualified and validated installation of SAS.