Big Brothers Big Sisters of Central Carolina’s Big Breakfast
Master of Ceremonies
Miss North Carolina USA
An attorney specializing in complex civil litigation, Cheslie Kryst loves to learn and develop her diverse range of interests. In addition to practicing full-time as an attorney at Poyner Spruill LLP, Cheslie runs a blog–White Collar Glam—that provides workwear fashion inspiration and resources for women.
Key Note Speaker
Belton “Money Rock” Platt
Dealing drugs, living without purpose or guidance from mentors, Belton “Money Rock” Platt would lose everything but his life. Overcoming inconceivable tragedies, Belton now strives to break the cycles of economic inequality for kids in Charlotte. By empowering them to discover a different path, one he never knew existed.
LMK Clinical Research is a proud sponsor of Big Brothers Big Sisters of Central Carolina. Register below at the link to:
- Celebrate the impact of one-to-one mentoring
- Recognize our Bigs of the Year
- Network with business and community leaders who are passionate about helping children discover their own potential
- Raise the funds needed to provide Big Brothers and Big Sisters to more children in our community
Technology continues to change the way we manage clinical trials and the Trial Master File is no exception. eTMF solutions are rapidly moving sponsors away from the inherent complexities and inefficiencies that come with paper filing onto an electronic storage medium that incorporates the TMF Reference Model taxonomy.
LMK’s focus on process optimization and inspection readiness of the TMF has given us the opportunity to work closely with many of the eTMF solution providers and our industry experts have built a strong technical knowledge-base of the solution ecosystem. From our perspective all the eTMF solution providers have unique features and functions that have the potential to add value to the TMF.
The key is establishing your eTMF requirements up front and matching those requirements to the capabilities of the various solution providers. LMK has helped a number of our clients with the eTMF solution selection process and we would love the opportunity to help you!
Please hover your mouse over the eTMF vendor solution provider’s logo’s below for a high level functional review. Clicking on the logo’s will take you to the solution provider’s web portal for more details.
About arivis’ Services
Our Clireo platform is a validated, Part 11 compliant end-to-end solution which removes the duplication of tasks caused by disparate systems. The Clireo modules include: eDMS, eQMS, eTMF, eCTD, and eMPM. We have hosted our applications in the Microsoft Azure cloud since 2010 and are recognized as a Microsoft Gold Certified Partner.
The Clireo platform can be used independently or together based upon a client’s requirements. The arivis team will support Clireo’s rapid implementation model and provide training on each module as part of the implementation. Our goal is to reduce your operating costs and help expedite the drug approval process for your organization. With a proven team of industry experts by your side we help you navigate the complex waters of our highly regulated industry.
About DRS eTMF OneSource
The DRS approach to Good Document Management at the clinical studies level begins with a robust software offering…one that features the industry’s most advanced safeguards. However, for studies whose current requirements call for the safeguards alone, we offer DRS OverSight and Audit Services which will keep your current software and TMF under constant surveillance with proactive monitoring by our Professional Services Audit Team. We call it DRS eTMF OneSource…you’ll call it perfect!
Be Inspection Ready 24/7… Using Your TMF Software or Ours.
About Florence Healthcare’s Services
The Florence eBinder Suite replaces paper investigator site files, trial master files and source binders with a shared platform. This shared platform approach makes remote monitoring of eRegulatory and eSource documents possible while giving sponsors real-time insights into study progress. Hundreds of sponsors and sites worldwide trust Florence eBinders to move past paper study roadblocks and enable new approaches to trial management. Florence is based in Atlanta, Georgia.
About MasterControl’s Services
The MasterControl eTMF Manager™ is an electronic trial master file management solution designed to enable real-time visibility into the status of all activities pertaining to a clinical study. Based on the TMF Reference Model, the eTMF Manager provides management of all documents, tasks, milestones and activities (such as monitoring visits and audits) required during a clinical trial, while allowing both sponsors and CROs to track the progress of pending, ongoing, and completed actions.
The MasterControl eTMF Manager is an out-of-the-box, best practice-configured document management system based on the TMF Reference Model. The MasterControl eTMF Manager provides:
- TMF-structured checklist template based on TMF Reference Model
- Integrated out-of-the-box document management system configuration of document types, templates, metadata, version control, lifecycle management, routes, and user roles for all TMF artifacts
- Secure collaboration environment to share and exchange content with internal and external contributors (i.e., sponsors, CROs, study sites)
- A user friendly “project plan” view of TMF artifacts and activities to ensure transparency and visibility into the status of all TMF activities
- Automated notification of milestones and task assignments via system and email to assignees (including external assignees)
- Easy to use bulk importing / exporting functionality for easy transfer of study documentation at study closeout
About Medidata’s Services
Medidata eTMF is a collaboration platform that empowers everyone – sponsors, sites, CROs – to seamlessly manage regulated content and actively maintain inspection readiness. Unified within the Medidata Clinical Cloud, Medidata eTMF allows users to create, store, view, edit and jointly work on an entire TMF life cycle in a single application with cutting-edge UX capabilities. With live content integrity verification, life science companies are using this fully-validated 21 CFR, Part 11 and Part 820-compliant system to assist them with their compliance obligations.
About Montrium’s Services
Montrium’s industry leading solution, Montrium Connect, offers a truly collaborative and compliant document and quality management environment on the cloud or on-premise.
Montrium’s proven eTMF Connect solution helps life sciences companies better manage their clinical trial documentation. It has been designed using the TMF Reference Model, and centralizes and standardizes your clinical records enabling both sponsors and CRO’s to contribute and access important clinical documents and information in real-time. eTMF Connect allows life sciences organizations to manage all of the essential documents required to be included in the Trial Master File/eTMF.
myClin: A Modern Approach to Your TMF Challenges
myClin is the world’s first Clinical Oversight Platform, offering state-of-the-art collaboration channels and the most documented, data-driven clinical trial oversight available. Now you might be wondering: How can myClin help meet my TMF needs? myClin acts as a real-time, central team document repository which streamlines Trial Master File (TMF) management. Study data is always accessible and can be tagged according to the TMF reference model 3.0. myClin enables a more dynamic TMF that sites and study staff alike can actually use and love.
The common TMF challenges our customers are addressing with myClin are:
- Fulfilling sponsor oversight obligations
- Automatically building an evidence trail of your supervision of CROs and other suppliers
- Moving beyond the wild and scary world of email for study communication
- Ensuring sites are trained and able to be compliant
- Always being inspection ready
Learn more about how myClin can meet your specific TMF challenges, and more, at myClin.com
About Phlexglobal’s Services
PhlexEview, their market leading eTMF, is used by of thousands of global users. Built to support both sponsors, sites and CROs across TMF management, PhlexEview offers:
- Wizard-driven eTMF completeness
- Unique intelligent placeholder technology
- Event-driven document management
- Customizable landing page dashboards
- Flexible TMF service models
- eISF with PhlexEisf
- eArchiving with PhlexEarchive
Phlexglobal offers a unique combination of cloud-based eTMF technologies that underpin their full service provision, software as a service or a combination of both. The choice is yours.
About ShareVault’s Secure Document Sharing System
ShareVault’s secure document sharing systems gives life sciences organizations the confidence to simply and securely share sensitive documents with third parties during due diligence activities, sponsor and regulatory audits, and in many other applications where confidential documents need to be secured, protected and tracked.
About Transperfect’s Services
Sponsors and CROs alike have selected Trial Interactive’s eTMF for its intuitive user interface, automation, expansive reporting and ease of remote inspections. It also uniquely features integration with a Study Start Up Module, ability to distribute regulatory documents electronically, encourage eISF with Site/Investigator access and aide in site training with a learning management system (LMS). Supporting ~ 3000 active studies, Trial Interactive enables life sciences companies to streamline the execution and commercialization of global clinical trials and collaborate on partnerships while reducing administrative burdens. As a 21 CFR Part 11 solution, the system also provides users with a completely secure environment in which to complete all required regulatory information, paving the way for paperless global clinical development and commercialization. Trial Interactive = Inspection Readiness.
About Wingspan’s Services
Wingspan eTMF focuses on enabling a sponsor to maintain an up-to-date, inspection-ready eTMF throughout a trial in support of agency requirements. Our TMF Planning Wizards allow an organization to plan the expected documents for a specific study by creating placeholders for documents based on the specific characteristics of the study.
Wingspan eTMF supports the three critical-to-quality measures most important to eTMF management: completeness, quality and timeliness. By making use of CTMS integrations, we are able to assign due dates to TMF documents and thus report on completeness on an ongoing basis, not just completeness based on what is needed by the end of the trial. This allows the TMF to be kept in a contemporaneous manner, in accordance with recent guidance from MHRA and other agencies. Users control criteria for reports and metrics to obtain the exact information they need.
Wingspan eTMF includes all of the features needed to plan, maintain, monitor and close out TMFs. Close-out checks ensure that the TMF is lock-ready, and a complete export package can be generated to allow compliant transfer or archive of the TMF.