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Core Services

Symbiance’s work has been excellent and they showed dedication to us and our timelines. There was frequent and clear communication, reliability and rapid data turn.

President,
Neuroscience Product Creation Unit
Just wanted to inform you that the NDA and MAA were successfully submitted to the relevant agencies — EARLY! This could not have been done without your expert services, including the QC staff.

Director, Medical Writing
Neuroscience Product Creation Unit
It would have been impossible to achieve [our goals] if you and your team didn’t work through weekends and under "crazy" timelines.

Associate Vice President
Global Therapeutic Area Head CNS II
I believe that the secret of our success has been in our ability to communicate directly and work as a team.

Associate Vice President
Global Therapeutic Area Head CNS II
We owe our success to their efficient and focused work, cooperative spirit and dedication.

Senior Director
Biometrics
Symbiance not only delivered all required information but was also exceptionally responsive to our needs.

Senior Director
Biometrics

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Core Services

Clinical Data Management Unit

Clinical Data Management Services

The Symbiance Way. Not just your CRO, your trusted partner to provide you with numbers that matter.

At our CDM unit, we provide services ranging from CDISC implementation and database design to creating quality assurance procedures.

Best practices are achieved by using best-in-class technology.

As an industry expert, Symbiance invests in leading data management technology, implementing and updating it consistently. Through the most up-to-date databases that adhere to 21 CRF Part 11 FDA regulations and have been validated by industry veterans, we analyze and manage clinical data for a new drug, from Phase I through Phase IV and beyond, helping to bring your drug to market. With speed. Accuracy. And confidence. To learn more about our CDM expertise, please click on the services listed below.

Clinical Data Management services customized for your study:

Database design and development

Customized to your clinical study requirements, we create databases through our CDM System (CDMS) with a fast and effortless set up. We strive for ease of use and flexibility to provide you with clean, accessible data.

We use the ClinPlus CDM system developed and distributed by DZS Inc. It is ideal for CRF tracking, data entry, data analysis, data cleaning, medical coding, and review and reporting on your clinical trials. Adhering to 21 CRF Part 11 FDA regulations, ClinPlus seamlessly integrates coding which supports standard and custom dictionaries, produces exceptional hit rates and includes sophisticated searching and browsing tools for manual coding.

At Symbiance, we customize the following three key components to set up your database, following precise, tested procedures:

Annotated CRF
This shows the domain and variable names that are used in building the database. This is the backbone of setting up a database that provides a channel for clean-flowing data to be accurately analyzed and precisely reported.
Database Design Specifications
This displays the entire layout of the database. Like a blueprint plan, this is your database’s map. Data design specifications are a vital step in delivering results with speed and accuracy.
Edit Check Specifications
In search of clean data, we provide lists of edit checks based on our expertise. Collaborating with our clients, we create a customized edit check list that is required to be programmed for fast set up of your clinical study and delivery of fast, accurate results.

Our promise of delivering numbers that matter is based on our activities that focus on maintaining the integrity and quality of your data.

Once we have created your customized database, we follow our rigorous standards of testing data to validate the database design, data entry screens and edit check programs.