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Core Services

Clinical Data Management Unit

For over twenty five years, Symbiance's CDM unit has been providing one of the most integrated and efficient data management services in the market.

Our CDM professionals, with a background in good clinical data management practices (GCDMP), bring extensive experience to the widely-used EDC systems.

Faster delivery, accurate data and essential drug development perspective improve your submission times and bring your drug to market with confidence.

Symbiance CDM team can be your Quality Gate of data coming from your Data management vendors.

Clinical Data Standardization

We are Subject Matter Experts in clinical data standards with a focus on helping clients leverage the CDISC SDTM and ADaM for both their internal practices/processes and regulatory submission. We leverage our extensive experience in clinical data standardization and integration services/solutions to help our clients successfully navigate the challenging waters of the clinical data life-cycle, from collection to eSubmission.

Our goal is to bring a unique value-added combination of technology and data standards together in an efficient way from both a time and resource/cost perspective to improve the flow of data from collection to eSubmission. We employ scalable best practices and tools for standardization of data from the collection source, statistical programming and development of the eSubmission deliverables.

Biostatistical Analysis Division

Symbiance has successfully delivered expert statistical analyses and SAS programming in all phases of drug development from a wide range of therapeutic areas for over twenty five years. Our biostatisticians and SAS ® programmers have built a reputation of industry expertise and unparalleled excellence by being trusted partners that provide reliable, on-time, quality deliverables while maintaining the highest level of scientific integrity.

Symbiance's Biostatistics Division consists of highly qualifed and experienced biostatisticians, with Ph.D.s leading our teams. The Division consists of experienced professional programmers who work closely with biostatisticians to create customized plans with data analysis timelines and validated deliverables, based on your needs. With seasoned professionals leading our programming team and expertise throughout the department, our Biostatistics Division hones its relationship for success by fully supporting the requirements of any project.

Medical Writing Unit

At Symbiance, our focus is our client. Our breadth of expertise, honed by over twenty years in the industry, helps us understand that clear, succinct reporting is the difference between a successful, fast-paced study and one stuck in the bogs. What you can expect from Symbiance is crisp reports that fit your submissions package and provide transparency on the progress of your clinical study. Customized writing and reporting is how we deliver results that count.

Symbiance's medical writers work collaboratively with CDM experts and biostatisticians to produce clinical writing deliverables that reflect the clinical experience and integrity of our firm. Our writers also have access to cross-functional internal teams with whom they collaborate on therapeutic areas so that the end result is a holistic, customized document. We also team up with medical writers that are trained in emerging biotechnological specialties and work with academics to prepare reports that enable secure submissions and more effective drug development.

Quality Gate Keeping Service

Not only can Symbiance provide the core services of data management and biostatistics, but we can also provide niche services to improve the quality, consistency and integrity of your clinical trial data, which we refer to as 'quality gatekeeping'.

One example of this is SDTM QC, which we are performing for few clients. We have dedicated team of SDTM experts for each of these customers and we have implemented programs that detect discrepancies between the SDTM delivery datasets/metadata against the sponsor's standards documentation. These discrepancies are then sent to the sponsor to be addressed and fixed in subsequent SDTM deliveries. This is a continuous process throughout the course of the study until the final SDTM delivery of the locked database. Another example is external data SDTM reconciliation, in which we compare the raw external data collection (i.e. labs, ecg, etc.) against the appropriate SDTM domain to ensure reconciliation is accurate at the SDTM level. Any discrepancy is sent to the sponsor/CRO for fixing in subsequent deliveries and is repeated until all discrepancies are resolved. Another example of a niche service is UAT testing of EDC systems. Being a small CRO allows us the flexibility to be trained and use any EDC of the sponsors choosing. Once trained, we can perform the appropriate testing and provide our UAT findings to the EDC development team for implementation. This approach allows issues to be addressed and fixed before the EDC system is deployed in a production environment. These are just a few examples of niche services we can provide to improve your clinical data quality. We are the extended team of the sponsor for data quality.

Area Of Expertise

Providing therapeutic expertise that delivers results

Over the past two decades, Symbiance has collected a wealth of knowledge and expertise in therapeutic areas relevant to pharmaceutical and biotechnology companies. Focused on therapeutic expertise in clinical and medical research that delivers results, with several NDAs and sNDAs, Symbiance expertise gives you the advantage when it comes to designing, managing, and analyzing the data for your in-progress drugs and devices.

Our therapeutic experiences can enhance your clinical development program

Our therapeutic expertise is integrated with our specialized capabilities. For over twenty years, this combination has enhanced our clinical development program no matter the therapeutic area.

Therapeutic Areas,

  • Oncology
  • Cardiovascular
  • Erectile Dysfunction
  • Hypertension
    • (Pulmonary Arterial)
  • Endocrinology
  • Rheumatology
  • Pain Management
  • Neuroscience
  • Women's Health
  • Hematology
  • Gastrointestinal
  • Dermatology
  • Respiratory
  • Infectious Diseases
  • Ophthalmology

CardioVascular

Our expertise includes the following:

  • Pulmonary Arterial Hypertension
  • Orthostatic Hypotension
  • Hypertension
  • Arrhythmia
  • Stroke

CNS

  • Pain Management
  • PHN (peripheral pain)
  • Headache Pain
  • Multiple Sclerosis (MS)
  • Epilepsy
  • Alzheimer's disease
  • Diabetic Peripheral Neuropathy
  • Postherpetic Neuralgia
  • Spasticity

Phase Expertise put to work for your clinical studies

From the early stages of drug development to post approval and beyond, Symbiance has created solutions for Phase I-IV clinical studies for over twenty years. When it comes to integrating our systems with our client's and seeing a study through to its end, Symbiance delivers data integrity in a model that provides cost and time efficiencies giving you results that count.

Both Symbiance and our partners have a wide range of therapeutic experience in Phase I through IV clinical trials. Recently, we completed also providing expertise in clinical operations. Recently, we completed also providing expertise in clinical operations. Recently, we completed enrollment on a study five months ahead of schedule.

A CRO with a recipe for results

Building relationships is the key to fostering a results-oriented culture. At Symbiance, we build relationships for success. Collaborating with our clients leads not only to cost savings and precisely implemented projects but, most importantly, trust-building communication that achieves results that count.

Symbiance as your choice of CRO

At Symbiance, we value developing long-lasting relationships with our clients and partners. We provide value through our actions. Clients return to Symbiance due to our commitment to quality and our culture of collaborative relationships. Delivery of accurate results on time, reliable technology and a passion for innovation leads to cost savings that Symbiance passes on to its clients.

Triangle

WHY SYMBIANCE

Reliable, Quality Clinical Data Management Services

High-quality data is a top priority at Symbiance's CDM Unit. But so is your time and your budget. Our dedicated team leaders help you process data that meet our rigorous standards. Always accurate, always accessible, and with a commitment to cost efficiency.

  • Niche services to improve the quality, consistency and integrity of your clinical trial data
  • External data SDTM reconciliation

Statistical analyses that offer solutions

Symbiance brings programming solutions that improve efficiencies for your study. We offer flexible solutions keeping you in mind.

  • Statistical analysis plans
  • Design and analysis of integrated summaries for safety and efficacy
  • Powerful statistical and clinical study reports
  • Publication and abstract support

Analytical services to meet your goals

  • Analysis plan development
  • Generation of data displays and reports
  • Protocol development/experimental design consulting
  • Efficacy and safety data analyses
  • Data analyses/meta analyses
  • Interim analyses
  • Stand-alone statistical reports
  • Integrated clinical/statistical study reports
  • Client-defined analysis standards
  • Collaboration with third parties for report and writing
  • Integrated summary of efficacy (ISEs)
  • CDISC SDTM mapping and conversion
  • CDISC ADaM programming and documentation

Our vast experience helps us deliver a portfolio of medical writing services to address the needs of every clinical research project

Symbiance's medical writers work collaboratively with CDM experts and biostatisticians to produce clinical writing deliverables that reflect the clinical experience and integrity of our firm. Our writers also have access to cross-functional internal teams with whom they collaborate on therapeutic areas so that the end result is a holistic, customized document.

We also team up with medical writers that are trained in emerging biotechnological specialties and work with academics to prepare reports that enable secure submissions and more effective drug development.

SAS Programming expertise

We offer solutions that are flexible, have fast set-up time and are customized with your results in mind. Whether a full-service study or a customized service, we collaborate with your in-house teams on your premises or ours. We're committed to fast, cost-effective results, following your SOPs and methodology - creating databases that are 100% compatible with yours.

The SAS programming sub-division is a niche division within Symbiance that focuses exclusively on results.

  • Generation of efficient data displays using Tables, Listings, and Figures (TLF) tailored to client's standards
  • Up-to-date versions of SAS

Other biostatistics services include

  • Protocol review
  • Statistical reports
  • Sample size estimation and re-estimation
  • Independent validation of results
  • Randomization schedules
  • Data Integration and Mining
  • Statistical Analysis Plans (SAP) creation/review
  • FSP model statistical Programming
  • DMC support

CDISC Services

  • CDISC implementation
  • Legacy and Ongoing data conversion to SDTM and ADaM
  • Up Versioning of SDTM using tool
  • Compliance evaluation utilizing both tools and SME reviews
  • Annotation of CRF/eCRF to SDTM using the SMART aCRF tool - www.smartacrf.com
  • Define.xml, Study Data Reviewers Guide (SDRG) and Analysis Data Reviewers Guide (ADRG) for SDTM and ADaM using the Define R3 tool - www.definer3.com

ABOUT US

Our Mission

Established in 1990, we began with the simple goal of providing clear, precise and timely solutions for the data needs of clinical trial professionals.

Today, Symbiance continues to apply this tradition of precision, clarity and performance to its expanded portfolio of services.

This includes a clinical data management unit, bio-statistical analysis and SAS programming, submission services and medical writing divisions.

Our Values

  • Provide clients with quality service on time.
  • Hire and maintain reliable professionals.
  • Establish and maintain open communication with our clients.

Our Tradition

Symbiance has a twenty five (25) plus year track record of success with clients such as, Eisai, Novartis, Progenics, Purdue, Wyeth, and Pfizer.

We strive for automation where ever possible in the clinical development life cycle and believe in scalability and cost effectiveness through automation.

Symbiance, as our name suggests, stands for mutually beneficial interactions and successful collaborations. It's what we strive for - to build a relationship for success.

Leadership Team

Shawki Salem, Ph.D

Founder

Shawki Salem, Ph.D. in Biostatistics, founded Symbiance - formerly Princeton Biostatistics Group PBG - in 1990, after spending seventeen years in the pharmaceutical industry as a Statistician, Senior Statistician, Director and Senior Director of Biostatistics

Ilango Ramanujam

President & CEO

Ilango, A Passionate Life Sciences Entrepreneur. Has over two decades of experience in Pharmaceutical, Bio-tech and CRO industry. Conceptualized and designed products to manage clinical data from collection to submission. Created and Built - Development and Services Teams - globally which delivered several regulatory critical systems in Clinical Data Sciences, with uncompromised quality to Pharmaceutical companies.

Saranga Ram

CIO

Saranga, A Life Sciences IT executive with strategy, execution and technology delivery experience in the Regulatory space and commercial web and mobile applications. Built several regulatory Systems in the Pharmaceutical industry after transitioning from the financial sector. His technical expertise includes - Cloud, Mobile, Open Source, Agile Methodologies, Dev ops, web and mobile application development.

Chao Chen Ph.D

Senior Director, Biostatistics

Chao has hands-on experience in statistical methodology as well as in-depth understanding of the underlying theory. His therapeutic experience covers a wide spectrum with significant contribution in neurology, oncology, cardiology and ophthalmology. Serving as an unblinded biostatistician and working closely with clinicians to review interim data under data monitoring committee set-up is another area Chao has dedicated to. In addition to coordinating all the biostatistical activities in clinical trials, he also published research articles in biostatistical and clinical journals.

Eric Weising

Director, Data Management

Eric, With over 15 years experience at Symbiance, Eric Weising is the Director of our Clinical Data Management Unit. By combining his critical thinking and problem-solving skills with his degree in Mathematics from Kean University, Eric has accumulated experience in Phases I-IV (with particular expertise in Phases II and III) and has substantial experience in such therapeutic areas as oncology, pain management, Alzeheimer's disease, depression/anxiety, epilepsy and hypertension. Eric's responsibilities have run the gamut from performing quality assurance of outputs (TLF) and SAS programming to clinical data management and biostatistical analysis.

Senthil Kumar

Associate Director, Statistical Programming

Senthil, A Clinical Data Expert, adept at developing tools for Data Analysis & Reporting, Data Extraction, TLF Generation, Derived Dataset Creation, DDT Generation, Patient Profile, MedDRA Mapping and Data Submission has managed teams for large Pharma's, for delivery of Submission Standards with proven excellence in managing Statistical Programming Activities for Data Summarization, Statistical Analysis and Reporting of Clinical Trials.

Contact Us

  • Address: Symbiance 231 Clarksville Road, Suite #1, Princeton Junction, NJ 08550, USA
  • Phone: 609-243-9050