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Symbiance, Inc.

Description: 

Over Twenty years in building and nurturing a relationship for success

 

For over 20 years, Symbiance has been a trusted partner to global pharma leaders.   As a renowned niche provider of Clinical Data Management, Biostatistics and Medical Writing, Symbiance is a CRO with strong core services that seamlessly blends in-house expertise with a network of long-term strategic partners.

 

Shawki Salem, Ph.D. in Biostatistics, founded Symbiance in 1990 after spending 17 years in the pharmaceutical industry as a Statistician, Senior Statistician, Director and Sr. Director of Biostatistics.   Today Symbiance has a successful track record of more than 20 years with clients both large and small.

 

Our achievements, past and current, are based, in large part, on the importance we place on nurturing the unique talents of our professional staff and the relationship we build with our clients.   Symbiance, as our name suggests, stands for mutually beneficial interactions and successful collaborations.

 

Symbiance's Values:

·           Maintain a "hands-on" senior management philosophy

·           Provide clients with quality service, on time and on budget

·           Hire and maintain experienced professionals with advanced degrees

·           Establish and maintain open communication with our clients — we are a trusted partner

·           Deliver strong core services with the ability to respond and adapt quickly to client needs

 

Symbiance services include:

 

Biostatistics


·           Protocol Review

·           Sample Size Estimation

·           SAP (Statistical Analysis Plan) creation/review

·           Provide Services to DSMB

·           SAS Programming for tables, listings & figures (TLFs)

·           Biostatistical Analysis – interim and final

·           Collaborate in writing clinical/statistical reports


 

Data Integration and Mining


·           Integrating multiple global clinical trials into a Global Data Repository (GDR)

·           Hosting, maintaining and updating the GDR

·           Services to DSMB

·           Mining data to support safety, marketing strategies and/or regulatory registration


 

Data Management


·           Electronic Data Capture (EDC)

·           Double data entry and verification

·           CRF design/development/review

·           Data queries and resolutions

·           Medical coding using the latest versions of MedDRA and WHO


 

CDISC Implementation

·           Mapping raw data to SDTM

·           Creating ADaM datatsets

 

Medical Writing


·           Clinical Study Reports (CSR)

·           ISS and ISE

·           Electronic Common Technical Documents (eCTD) for NDA and BLA


 

Expertise in a Wide Range of Therapeutic Areas


·           Pain, Epilepsy, Alzheimer's Disease and Parkinson's Disease

·           Leukemia and Solid Tumors

·           Infections and Severe Sepsis

·           Cardiovascular, Gastric Ulcer and Rheumatology


 

Services: 

Clinical Study Reports, Clinical Trial Monitoring, Data Management, Electronic Data Capture, Electronic Submissions Preparation, Medical Writing, Programming (Database/SAS/etc), Quality Assurance/Control, Regulatory Document Preparation, Statistical Services/Meta Analysis

Contact Information: 

Symbiance, Inc.
231 Clarksville Road, Suite 1
Princeton Junction, NJ, 08550, USA
Phone : 6092439050
Fax : 6092439007
Internet : www.symbiance.com
Email : info@symbiance.com
Contact Person : Shawki Salem, President