Services

KEY PROJECTS

Enterprise Modeling (BRIDG, LS DAM, and BAM)
Samvit analysts are the modelers for the Biomedical Research Integrated Domain Model (BRIDG) and the Life Sciences Domain Analysis Model (LS DAM). These models are UML class diagrams that represent the data semantics of the protocol-driven research and the life sciences domains. The BRIDG model is collaborative effort engaging four stakeholders and their communities to build a common model representing a shared understanding of the domain of clinical research.  The BRIDG model has become a de-facto industry standard for representing the semantics of clinical research. The stakeholders of the BRIDG model are the US National Cancer Institute (NCI), Clinical Data Interchange Standards Consortium (CDISC), US Food and Drug Administration (FDA) and Health Level 7(HL7).

Our analysts/modelers work collaboratively with members from CDISC, FDA and HL7 to harmonize the data semantics from various clinical research related projects and represent the data in the BRIDG model - a UML class diagram.  Our analysts working experience in building clinical research related software solutions over the past 15 years have provided us with deep understanding of both the clinical research and the life sciences domains. 

We have also developed the Clinical Research Business Architecture Model (BAM). The Clinical BAM captures all the activities and functions that occur at cancer centers during the planning and execution of clinical trials. These activities have been documented as UML Use Case diagrams.  Samvit analysts worked extensively with the cancer center community to build consensus, facilitate discussions and collectively documented over 150 clinical research use cases that describe the processes and functions of clinical trials - from protocol authoring to study execution.  Our team also worked with the subject matter experts to build detailed interoperability scenarios in support of cross-application interoperability.  Details of these business scenarios were documented as UML use case diagrams and activity diagrams.  We have successfully performed the role of enterprise modelers on all these initiatives for the last 6 years at a major Health and Human Services agency.

Clinical Trials Reporting Program (CTRP)
CTRP is a strategic initiative for the National Cancer Institute (NCI) which has required re-engineering many existing business processes of NCI in relation to registration of cancer clinical trials at NLM's ClinicalTrials.gov. Samvit team members have been the lead analysts on NCI's CTRP since its inception in 2007. We have successfully led this analysis effort and have been responsible for all business and technical analysis, modeling and design activities of the CTRP system and its reporting database. We interface extensively with all the stakeholders of CTRP to gather and analyze business requirements and build detailed implementable technical specifications for the development team. In our role as analysts on this team, we are also responsible for designing the database model and the data warehouse model in support of the reporting requirements.  This experience has provided us with expertise in NLM's ClinicalTrials.gov trial registration processes and requirements.

Biospecimen and Biobanking Vocabulary Development
Samvit leverages our analysis and standards development expertise to support the standardization of meta-data in a biospecimen & biobanking initiative. This is an enterprise level vocabulary development effort and leverages exisitng standard terminology such as CPT,  National Drug Code list, ICD10 as well as domain expert defined value sets.  

2016

  • IBM - FDA Clinical and Nonclinical Repository Subcontract

Samvit Solutions joins the IBM team in providing requirements analysis services on FDA’s Clinical and Nonclinical Repository project.

  • Attain - National Cancer Institute (NCI) - BRIDG Model

Attain renews the BRIDG modeling and maintenance contract. BRIDG is a Domain Information Model for Translational Research and a collaboratively effort between NCI, CDISC, FDA, HL7 and ISO. To learn more visit www.bridgmodel.org.

  • FDA Grant

The FDA awards Samvit Solutions a Grant for BRIDG Architecture.

  • IBM - FDA Subcontract

IBM renews FDA subcontract to Samvit Solutions for providing requirements analysis, data standardization and modeling services.

  • Leidos Biomedical at the NCI - CTRP Program

Leidos Biomedical at the NCI renews SemanticBits/Samvit Solutions contract for continued support of business and technical analysis for the NCI’s Clinical Trials Reporting Program (CTRP).

  • Transcelerate BioPharma

Transcelerate BioPharma renews Samvit Solutions CDISC support consulting contract.

  • Digital Infuzion - NCATS Subcontract

Digital Infuzion renews NCATS subcontract to Samvit Solutions for providing requirements analysis services.

 

2015

  • IBM - FDA Subcontract

IBM awards FDA subcontract to Samvit Solutions for requirements analysis, data standardization and modeling services.

  • Attain - National Cancer Institute (NCI) - BRIDG Model

Attain renews the BRIDG modeling and maintenance contract. BRIDG is a Domain Information Model for Translational Research and a collaboratively effort between NCI, CDISC, FDA, HL7 and ISO. To learn more visit www.bridgmodel.org.

  • Leidos Biomedical at the NCI - CTRP Program

Leidos Biomedical at the NCI re-news SemanticBits/Samvit Solutions contract for continued support of business and technical analysis for the NCI’s Clinical Trials Reporting Program (CTRP).

  • Transcelerate BioPharma

Transcelerate BioPharma renews Samvit Solutions CDISC support consulting contract.

  • Digital Infuzion- NCATS Subcontract

Digital Infuzion awards NCATS subcontract to Samvit Solutions for providing requirements analysis services.

 

2014

  • Samvit Solutions CEO, Smita Hastak, to present at DIA 2014

On June 18, 2014, Ms. Hastak will present a session titled: "A Case Study in BRIDG Implementation: Leveraging BRIDG as a Database Model for Clinical Trials" at the Drug Information Association (DIA) 2014 Annual Meeting in San Diego, CA.

 

2013

  • Leidos Biomedical Research, Inc. (formerly SAIC-F) awards a Basic Ordering Agreement (BOA) to Samvit Solutions

Samvit Solutions has been awarded the BOA for areas of Information Architecture, Business analysis and Requirements Analysis

 

  • NCI and SAIC-F re-new the Clinical Trials Reporting Program (CTRP) contract for SemanticBits and Samvit

Samvit will continue to work with SemanticBits team to provide the business and technical requirements analysis services for NCI’s Clinical Trials Reporting Program (CTRP).

 

  • Transcelerate Biopharma, Inc. consulting contract

Samvit team will provide analysis and meta-data standardization consulting services to the CDISC SHARE meta-data repository and the therapeutic area standards development initiative from CFAST

 

  • CDISC re-news BRIDG training and consulting contract

Samvit Solutions will continue to provide the BRIDG Deep Dive Training for CDISC as their authorized BRIDG trainer. Samvit will also provide support for CDISC standards development efforts in relation to Therapeutics Area standards development and other initiatives

 

2012

  • NCI and SAIC_F award the BRIDG Modelling contract to Samvit

Samvit has been awarded the BRIDG modelling and maintenance contract. Samvit team members have been active participants of the BRIDG model for many years and work closely with the various stakeholders (NCI, CDISC, FDA, HL7) of BRIDG and their member communities to perform the task of semantic alignment, integration and building of the collaborative model for protocol-driven research.

 

  • Samvit joins the Trifecta Solutions and CACI team on the U.S. Navy Medicine NMKMS Project:

Samvit Solutions is responsible for collecting and reporting the operational workload data of deployed U.S. Navy medical units. This information is made available via the Navy Medicine Knowledge Management System (NMKMS). Samvit is also responsible for the requirements analysis, design, and test of the Medical After Action Reporting System (MAARS). MAARS' objective is to help assess the performance and effectiveness of U.S. Navy Cooperative Health Engagements (CHEs) conducted at the Combatant Commands (COCOMs) worldwide. This project illustrates Samvit's capability to collect a complex set of new concepts developed by subject matter experts and produce clear system requirements, models, and design artifacts to support developing a system that satisfies the client' original vision.

 

  • NIH Director’s Group Award to Samvit employee on CTRP:

Samvit employee Farhan Khan is a recipient of NIH Director’s Group Award for contribution in Bio-marker Nomenclature and Database Committee for NCI’s Clinical Trials Reporting Program (CTRP) project.

 

  • Samvit at CDISC International Interchange 2012, Baltimore:

Samvit’s Smita Hastak, participates as a panel member in the “Information Requirements for Therapeutic Area Standards” session at the interchange.

Samvit employees Wendy Ver Hoef and Smita Hastak provide BRIDG Training at the Interchange.

 

  • NCI and SAIC_F award caHUB Vocabulary analysis contract to Samvit

Samvit provides analysis services for the development of the cancer Human Biobank (caHUB) Enterprise Vocabulary repository and support the CDR vocabulary requirements. caHUB is an initiative from NCI’s Office of Biorepositories and Biospecimen Research (OBBR).

 

2011

  • NCI CBIIT Awards CTRP contract to SemanticBits and Samvit

Samvit Solutions analysts continue to provide all business and technical analysis services to NCI’s Clinical Trials Reporting Program (CTRP). As analysts on the project, Samvit team works with the subject matter experts and end users to understand the business needs and then build detailed implementable technical requirements for the SemanticBits development team.

 

  • CDISC engages Samvit for BRIDG training and other consulting work

Samvit is now a CDISC authorized BRIDG trainer. We are the only CDISC authorized BRIDG trainers. To request a in-house private BRIDG training, please go to -- http://www.cdisc.org/content4148

 

At Samvit, we help our clients effectively manage and execute a variety of information technology programs. In addition to employing well establish project and program management processes, our approach begins with establishing trust and creating an environment of collaboration between stakeholders. Trust and reliability have always been the cornerstones to delivering our services.


Our clients' business strategy and vision are directly linked to successfully executing their projects. By following a standard project management methodology, such as those prescribed by the Project Management Institute (PMI) and Scrum Methodology, our clients are constantly informed of project progress, potential risks, and the status of deliverables, as they watch their projects advance in alignment with their business objectives.

 

National Cancer Institute - Division of Cancer Prevention (DCP)

Samvit provides program management support to multiple projects at the DCP including DCP's DESK Clinical Trials Management system, and the DESK-CTRP Integration Module (DCIM). Samvit is responsible for overseeing the development, operations and maintenance activities. In addition, we coordinate among a number of stakeholders to ensure transparency and constant communication while providing quality service. We work diligently to provide our client clear visibility over project activities, progress, financials and overall status.

 

Samvit Solutions is a health informatics company focused on providing business and technical requirements analysis, standards development and program management services in the healthcare and life sciences initiatives. We provide enterprise level business process analysis, systems modeling, and requirements analysis services to software development efforts. We partner with development companies to provide a complete software solution. Samvit team members are active participants in the clinical research data exchange standards development efforts. Our core capabilities include:

  • Business Process Modeling
  • Requirements Analysis & Systems Modeling
  • Data and Vocabulary Standards Development
  • Semantic Integration in Clinical Research Domain
  • Program Management

 

Samvit Solutions is the only CDISC authorized BRIDG trainer. We provide BRIDG training at all CDISC Interchanges in the US as well as internationally.

BRIDG Logo

 

 

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