Professional Services

With over 15 years supporting thousands of clinical trials, we provide high quality, proven professional services on top of our solutions to ensure your clinical trial success!

Need help with an upcoming study? Looking for some technical assistance? Training?
We offer professional services in the following areas:

Study Build Activities

Whether you want just 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 teams to get the build done right.

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 a detailed project plan with clear deliverables, data mapping specifications, and validation. Bring all your studies into the OC4 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!
Annotated 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.
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.
Staff Augmentation (Coming Soon)
At times your organization may be faced with resourcing challenges, which could result in short or long term needs that you have to address. OpenClinica offers a dedicated resource model that can provide you with consultant support spanning study design, including project management, amendments, import, report configuration, training and many of the other services listed above. The goal is to provide you with resource flexibility and operational efficiency.

Our dedicated Consultants can work with you under either of the following models:

Embedded Employee: The Customer will retain overall accountability and management of the study direction and work assignments. Customer SOPs and other guiding principles support the operating model. OC personnel act as an extension of your organization with full access to any additional tools and systems used by the Customer. They are fully dedicated to the Customer for the set period of time as agreed upon.

Enhanced FTE: The Customer will still retain overall accountability and management of the study direction. However, Customer may agree that OC SOPs and other principles will govern the operating model. OC personnel may vary based on work assignments but agreed upon FTE amount will still be fulfilled. This scenario may be more beneficial in cases where you need less than 20 hours (.5 FTE) per week over a few months time-frame.

Reports & 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.
Training (SUT, End User, Monitors, DMs, IMs)
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, monitors, study designers, project managers, and other centralized users 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.

In addition, 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.

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

eCRF Completion Guidelines
Creating good eCRF completion guidelines (a/k/a instructions) can be tricky and time consuming. Don’t go at it alone—let us work with you every step of the way. We’re even available to review your final product for that “last look” before it’s circulated.
Data Management Plans (DMP)
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!
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!
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 & regulatory expertise is here for you!
Study Rescue (Coming Soon)