Professional Services

With over 15 years of experience supporting thousands of clinical trials, OpenClinica’s professional services team knows how to ensure your clinical study is a success.

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Case Study: When a Data Manager Leaves Mid-Study Build

If you’ve ever been in the middle of designing a clinical trial, you can imagine the challenges that arise if your sole clinical data manager resigned. When this happened to one of our customers, OpenClinica was able to immediately fill the gap with a talented, experienced Solutions Consultant to complete the study design and build activities, allowing the trial to stick to its original timeline.

Case Study: Migrating from a Legacy System

One of our customers running a multi-decade study began a complex platform trial many years ago on an antiquated system that lacked the capabilities that are now desired and necessary for a successful trial. Their study was complex with a large volume of historical data. Despite these challenges, OpenClinica’s professional services team successfully migrated the study to the OpenClinica platform, while helping all users (research coordinators, data managers, etc.) manage the transition seamlessly. If you’re unhappy with your current electronic data capture (EDC) platform, you don’t have to wait it out. OpenClinica has performed data migrations for dozens of studies. We can help you move from any platform onto OpenClinica for better data, faster.

Case Study: Automating and Integrating to Enhance Quality and Scale

A leading clinical laboratory services company that runs dozens of small “micro-studies” on behalf of its clients was using paper-based processes combined with homegrown software that lacked efficiency. The company was looking for something better. They piloted and conducted an extensive evaluation of numerous EDC systems, but until they came across OpenClinica, they could not find an eclinical system capable of supporting their unique workflow and integration needs. With OpenClinica, this customer was able to automate and scale their operations to support their large volume requirements, stating: “Flexible and agile design with robust web services – OpenClinica delivers… The OpenClinica design tools make it easy for non-technical resources to make, test, and then deploy changes while maintaining compatibility with previous iterations.”

Study Build Activities

Study Build Activities

Whether you want to grab a few hours from an expert to build a complex form, or need a team to perform a complete study build and validation, OpenClinica’s Solutions Consultants are here to help. We offer flexible models for working alongside your team to get the build done perfectly for your trial.

Reports and Dashboards

OpenClinica can provide expert resources to help make sure you are able to get the reports/visualizations and alerts your stakeholders need via OpenClinica Insight™. We’ll help you understand how best to extract intelligence from your data to keep your studies humming.

Library Creation & CDASH Standards

Content standards accelerate study go-live, promote reuse of data, and facilitate regulatory submissions. OpenClinica’s professional services team helps customers develop libraries of well curated, reusable forms and items, and align them with standards such as CDASH.

Data Migrations

Moving your studies and data shouldn’t be painful. You shouldn’t be constrained to carry out your studies on a legacy system. Let us guide you through our process, providing you with a detailed project plan and clear deliverables, data mapping specifications, and validation. Bring all your studies into the OpenClinica platform while utilizing a process that manages risk, focuses on quality, and gives you peace of mind.

Integrations

Perhaps you’re using some homegrown systems or even other off-the-shelf solutions for labs, IxRS, CTMS, payments, and more. OpenClinica’s advanced web services API makes it possible to interchange data with these systems in real time. Our team can work with your organization and third-party vendors to bring it all together!

Training

SUT, End user, monitor
Super User Training (SUT)

OpenClinica offers a variety of effective training courses for various stakeholders. For example, OpenClinica Super User Training is a comprehensive course that prepares data managers and study designers to productively work with OpenClinica. This highly interactive, in-depth course is designed and taught by the same professionals who design, build, and test the OpenClinica software .

End User Training

Role-based End User Training can be developed and delivered to suit your immediate needs, allowing key features and functionality to be catered to each role for ease of understanding and reference by site personnel.

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Learning Management System (LMS)

Complimentary with the purchase of your subscription, the LMS training is focused on the four (4) core end user roles of Data Manager, Clinical Research Coordinator, Monitor, and Principal Investigator. Each course has been designed to clearly outline learning objectives, provide focused course content for the responsibilities of each user role, and confirm understanding of the subject matter with a quiz and subsequent certificate of completion upon receiving a passing quiz grade. Request LMS training here.

Investigator Meeting Training

Looking for OpenClinica to play a more interactive role in your Investigator Meeting? We’re happy to provide system training, key feature overviews, and more as part of your study launch.

Design Best Practices Workshop

OpenClinica’s Design Best Practices training will teach you the guiding principles of study design; who is responsible for study design and what each role is accountable for; how to create libraries and implement CDASH standards; and how to scope, manage timelines, and test your study design process before implementation.

Other Services

CRF
Electronic Case Report Form (eCRF) Completion Guidelines

Creating good eCRF completion guidelines (also known as instructions) can be tricky and time consuming. Don’t go at it alone—let us work with you every step of the way. We can also review your final product for that “last look” before it’s circulated.

Data Management Plans (DMPs)

A well-designed DMP will provide a roadmap on how to handle the data, establish processes to address unforeseeable conditions, and assess potential risks. Your DMP will ensure your study database is accurate, reliable, secure, and ready for analysis. Leverage our experience whether you are just starting to author the document or you are looking for an expert-review after it’s created. We are here to help!

CRF
Annotated Case Report Forms (CRFs)

OpenClinica can help you generate annotated eCRFs, customized to your specific needs. We can execute this process for you or show you how to do it on your own.

Data Transfer Agreement

A DTA governs the transfer and use of human personal data that is made available by a provider to the entity that wishes to use this research data for its own research purposes (recipient). It is designed for cases where no cooperation agreement exists between the contractors. Is your DTA template extensive enough? Are you looking for that expert review after it’s authored? Our consultants and compliance & regulatory teams have the expertise to ensure compliance and data security.

SDTM
SDTM Conversion

OpenClinica professional services can help accelerate your regulatory submissions for helping you get your data into submission-ready formats, including SDTM, Define-XML, CDASH, SEND, and ADaM.

SOP development
SOP Development

Getting hung up on SOP development or review? Not quite sure if you’ve covered the necessary items and perhaps short on resources to pull this together? We can assist with full SOP creation or even with review after you’ve authored your SOPs. OpenClinica’s compliance and regulatory expertise is here for you!

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