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  • expertisetechnical services

    Our professional expertise and extensive industry knowledge provide your organization with the assurance of high performance solutions and met targets.

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  • dedicated toclients & employees

    We deliver a consistent client commitment through a philosophy geared toward building genuine, long-lasting relationships. No matter how large or small the project, the level of personal service and focus that clients receive remains unmatched.

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welcome

At etera solutions, we bring an innovative and integrated approach to technical/programming solutions in the clinical development process. Our solutions rest on expertise and intelligence, solving technical problems from data collection to data submission.

etera solutions—a more knowledgeable, focused, and agile new model for today’s technical solutions providers.

etera solutions is a consulting and functional service provider dedicated to providing high-quality technical and programming solutions for the healthcare, medical device, biotechnology and pharmaceutical industry. We combine unmatched expertise with transparency to create integrated solutions across all clinical functions. Our clients include global companies, emerging start ups, and mid size firms.

The key elements that define etera solutions are accountability, expertise, and commitment.

Accountability

We are responsible, transparent, and ethical. We take a collaborative approach, share knowledge, and work with clients to develop a clear path to achieve project goals.

Expertise

Our focus is technical services. Our professional expertise and extensive industry knowledge provide your organization with the assurance of high performance solutions and met targets.

Commitment

We are dedicated to our clients and employees. We deliver a consistent client commitment through a philosophy geared toward building genuine, long-lasting relationships. No matter how large or small the project, the level of personal service and focus that clients receive remains unmatched.


partners

services

  • We provide expert, in-depth advice on management, processes, and systems. We collaborate closely with our clients to help them build efficient and reliable technical processes within their clinical development environments.

  • We provide integrated programming teams who deliver measurable results with every engagement. By using seamless, best-of-class solutions onsite, your clinical development process is virtually uninterrupted.

  • We deliver quality results with a minimum footprint. Our internal teams can use a client’s infrastructure remotely or execute the work within our own structure, depending on your needs.

  • Combining our expertise and consulting capabilities, On-Demand brings a wide array of services to your problem solving.

    • Implementation and Validation
    • Clinical System Implementation and Validation
    • EDC Implementation Plan Design
    • Applications Development
      Database Programming
    • Trial Setup, Including CDISC Compliant CRFs
    • Global Library Management
    • Edit/Validation Check Development
    • Vendor Data Transfer Programming
    • Medical Dictionary Management
    • Trial Locking and Archiving Activities
      Statistical Programming
    • Statistical Table, Listing, and Figure Programming
    • Data Monitoring Programming
    • Analysis Dataset Programming
    • Validation of Statistical Outputs
    • Integrated Summary Programming
    • Ad Hoc Programming
      CDISC
    • CDISC/SDTM/ADaM/eCTD Programming Support for FDA Submissions
    • Budgeting Management Strategy
    • In-Sourcing Management Strategy
    • Out-Sourcing Management Strategy
    • Process Improvement Strategy
    • Technology Strategy
    • Management of In-Sourced Staff
    • Management of Out-Sourced Staff
    • Standard Operating Procedure Development

news

  • etera solutions opens new office in North Carolina

    Posted by Admin. on: Friday, April 15, 2016

    etera solutions is pleased to announce the opening of a new office in Chapel Hill, North Carolina. The office will address the growing demands of the Biotech, Pharma, Medical Device, and Health industries for management, process, and technology resources. Elizabeth Singer, Managing Director, will lead our efforts in the new location.

  • CIOReview recognizes etera solutions

    Posted by Admin. on: Friday, March 25, 2016

    etera solutions is proud to be recognized in CIOReview’s March 25th Biotechnology Special issue as one of the 20 most promising biotechnology solution providers. A link to the article is here http://biotech.cioreview.com/vendor/2016/etera_solutions

  • etera solutions attends PhUSE

    Posted by Admin. on: Thursday, May 14, 2015

    Our Director of Business, Gerry Montgomery, attended the PhUSE meeting in New York on May 14th. Gerry is a Co-Lead for all PhUSE Single Day Events. The New York event was well attended, and the general topic was “Using and Sharing Metadata.”

  • etera solutions sponsors PhUSE discussion on Implementation Standards

    Posted by Admin. on: Friday, July 11, 2014

    etera solutions is proud to sponsor the PhUSE Single Day Event discussion on Implementation Standards. This event will take place on August 20, 2014, in Bridgewater, New Jersey. Gerry Montgomery, our Director of Business Development, will be participating in this event and looks forward to discussing this topic, and the many other topics of the meeting. Please call or email Gerry if you’d like to meet with him during this event to discuss our EDC and statistical programming services.

  • etera solutions contributes to CDISC SDTM-IG 3.2 / SDTM 1.4

    Posted by Admin. on: Tuesday, November 26, 2013

    Carlo Radovsky, Managing Partner at etera solutions, participated in CDISC’s efforts in releasing SDTM-IG 3.2. The document contains significant updates, as well as a redesigned format, making it both easier to maintain and read.

Archives

etera solutions presents at BACUN quarterly meeting

Posted by Admin. on: Friday, September 13, 2013

Carlo Radovsky, Managing Partner at etera solutions, presented Taming the SHREW (SDTM Heuristic Research and Evaluation Workshop) at the Boston Area CDISC User Network (BACUN) quarterly meeting in Lexington, MA.

etera solutions attends CDISC-All-Team INTRAchange 2013

Posted by Admin. on: Tuesday, July 30, 2013

Carlo Radovsky, Managing Partner at etera solutions, attended the 2013 CDISC INTRAchange in Maryland. This three-day meeting brought together members of all CDISC teams to brainstorm on emerginng challenges.

etera solutons attends DIA 2013 49th Annual Meeting

Posted by Admin. on: Sunday, June 23, 2013

Reed George and Subbu Rayavarapu, both Managing Partners, along with the business development team, attended the Drug Information Association 2013 49th Annual Meeting in Boston, MA. The group joined the booth of one of their Business Partners.

etera solutions presents at BACUN quarterly meeting

Posted by Admin. on: Friday, January 11, 2013

Carlo Radovsky, Managing Partner at etera solutions, presented an overview of SDTM developments, from SDTM 3.1.2 Amendment 1 to SDTM 3.1.4, at the Boston Area CDISC User Network (BACUN) quarterly meeting in Lexington, MA. He also participated in the steering committee to help plan and organize for future BACUN meetings.

etera solutions completes milestone in CDISC SDTM and ADaM conversions

Posted by Admin. on: Thursday, December 13, 2012

Etera solutions is excited to announce the completion of our 75th trial conversion into CDISC STDM or ADaM format. The conversions included both legacy and on-going clinical trial data, in all clinical development phases.

etera solutions partners with CURO Clinical Data Management, Inc.

Posted by Admin. on: Wednesday, January 11, 2012

CURO Clinical Data Management is a contract research organization, specializing in clinical data management in support of clinical trials in the pharmaceutical, biotechnology, and medical device industries. Their seamless integration between clients, vendors, partners, and sponsors enables them to work rapidly and efficiently while providing the highest quality customer service, flexibility, and attention to detail in the industry.

For more information, please visit www.curocdm.com

etera opens new office in India

Posted by Admin. on: Thursday, May 5, 2011

Etera solutions is pleased to announce the opening of a new office in India. This office will address the growing demands of life sciences expertise, in terms of management, process, and technology.The new office is located in Chennai, India.

etera solutions partners with Merge Healthcare

Posted by Admin. on: Monday, April 25, 2011

Merge is a leading provider of clinical systems and innovations that seek to transform healthcare. Merge eClinical solutions are delivered as a single clinical trial operating platform that are available anywhere, any time. Clinical trial capabilities can be mixed and matched to build a solid foundation for each trial environment. One interface, one consistent experience, one platform.

For more information, please visit www.merge.com/eclinical

etera solutions Managing Partner is appointed Co-chair of Products and Services for SCDM

Posted by Admin. on: Friday, April 1, 2011

Carlo Radovsky, Managing Partner at etera solutions, is appointed Co-chair of Product and Services for SCDM (Society for Clinical Data Management).

As Co-chair, Carlo supports the Products and Services team and various sub-teams in their efforts. Areas include the CCDM exam and GCDMP.

etera solutions completes milestone in CDISC SDTM and ADaM conversions

Posted by Admin. on: Tuesday, February 1, 2011

Etera solutions is excited to announce the completion of our 50th trial conversion into CDISC STDM or ADaM format. The conversions included both legacy and on-going clinical trial data, in all clinical development phases.

etera solutions attends OMOP conference

Posted by Admin. on: Tuesday, January 11, 2011

Reed George, Managing Partner at etera solutions, attended the Observational Medical Outcomes Partnership’s 2011 Symposium in Washington, D.C. The Symposium centered on the results, tools, and key lessons from the OMOP research program. Members of the OMOP research team, advisory board, and executive board discussed OMOP’s accomplishments and ongoing research agenda.

etera solutions presents at BACUN quarterly meeting

Posted by Admin. on: Wednesday, September 15, 2010

Carlo Radovsky, Managing Partner at etera solutions, participated as a panelist on the topic of ADaM at the Boston Area CDISC User Network (BACUN) quarterly meeting in Waltham, MA.

etera solutions attends CDISC conference

Posted by Admin. on: Wednesday, November 11, 2009

Carlo Radovsky, Managing Partner at etera solutions, attended the 2009 CDISC Interchange, North America. This annual conference is a collaborative event to share progress, implementation experiences, and strategic ideas on worldwide data interchange standards for medical research.

etera solutions co-authoring a new chapter for SCDM

Posted by Admin. on: Tuesday, November 10, 2009

Carlo Radovsky, Managing Partner at etera solutions, is co-authoring the new “System Validation” Chapter in the Good Clinical Data Management Practices (GCDMP) guide for the Society for Clinical Data Management.

etera solutions reviews a new chapter for SCDM

Posted by Admin. on: Thursday, October 22, 2009

Subbu Rayavarapu, Managing Partner at etera solutions, reviewed and commented on the “Data Acquisition” Chapter in the Good Clinical Data Management Practices (GCDMP) guide for the Society for Clinical Data Management.

etera solutions joins OMOP team

Posted by Admin. on: Friday, October 16, 2009

Reed George, Managing Partner at etera solutions, joined the Observational Medical Outcomes Partnership’s Statistics and Programming Team. From OMOP’s Website: “OMOP is a public-private partnership designed to help improve the monitoring of drugs for safety. The partnership is conducting a two-year initiative to research methods that are feasible and useful to analyze existing healthcare databases to identify and evaluate safety and benefit issues of drugs already on the market.” He will provide statistical programming services to the team.

etera solutions presents at annual SCDM conference

Posted by Admin. on: Monday, October 5, 2009

Arvind Gopal, Principal at etera solutions, presented “CDM Leveraging Standards” at the 2009 Society for Clinical Data Management Annual Conference in Seattle, Washington.

etera solutions relocates office

Posted by Admin. on: Saturday, August 1, 2009

To accommodate our growing needs, etera solutions corporate office relocated to a new address. The new address is 354 Turnpike Street, Suite 203, in Canton, MA, 02021.

etera solutions is selected as a Subject Matter Expert of a chapter for SCDM

Posted by Admin. on: Thursday, June 11, 2009

Arvind Gopal, Principal at etera solutions, was selected as a Subject Matter Expert for the External Data Transfer Chapter in the Good Clinical Data Management Practices (GCDMP) guide for the Society for Clinical Data Management.

etera solutions reviews a new chapter for SCDM

Posted by Admin. on: Tuesday, June 9, 2009

Arvind Gopal, Principal at etera solutions, reviewed and commented on the “Edit Check Design Principles” Chapter in the Good Clinical Data Management Practices (GCDMP) guide for the Society for Clinical Data Management.

etera solutions adds an intern program

Posted by Admin. on: Monday, June 8, 2009

Etera solutions is pleased to announce its new internship program. This program allows etera solutions to work with local colleges and universities, along with local industry, to identify potential database and statistical programmers and to provide skills needed to work in the Biotechnical/Pharmaceutical programming fields.

etera solutions adds a new service

Posted by Admin. on: Thursday, June 4, 2009

Based on client needs, etera solutions added an on-demand service to our list of services. Clients can now use our services as needed, whenever needed.

etera solutions completes milestone in CDISC SDTM and ADaM conversions

Posted by Admin. on: Monday, June 1, 2009

Etera solutions is excited to announce the completion of our 25th trial conversion into CDISC STDM or ADaM format. The conversions included both legacy and on-going clinical trial data, in all clinical development phases.

etera solutions joins CDISC, SDS team

Posted by Admin. on: Friday, May 22, 2009

Carlo Radovsky, Managing Partner at etera solutions, joined the Submission Data Standards (SDS) Team of the Clinical Data Interchange Standards Consortium (CDISC). CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The SDS team is responsible for the maintenance and ongoing development of CDISC’s Study Data Tabulation Model (SDTM), which defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).

etera solutions launches a new website

Posted by Admin. on: Tuesday, April 21, 2009

Today, etera solutions, a consulting and functional service provider dedicated to providing high-quality technical and programming solutions for the biotechnology and pharmaceutical industry, is pleased to launch their redesigned website. As part of the redesign, etera solutions added new services and partnerships. Its logo also received a new facelift.

etera solutions adds strategic partnerships

Posted by Admin. on: Wednesday, March 25, 2009

Etera solutions is pleased to announce its new strategic partnership plan, Best-of-Breed Partnership or BBP. Under this plan, etera solutions will partner with leaders in the industry, including persons in the Biostatistics/Statistics, Data Management, Medical Writing, and Dictionary Coding fields. The plan allows etera solutions to identify, partner, and collaborate with the best of these fields both locally and nationally.

etera solutions partners with KIKA Medical, Inc.

Posted by Admin. on: Thursday, February 19, 2009

etera solutions joins BACUN Steering Committee

Posted by Admin. on: Monday, August 4, 2008

Carlo Radovsky, Managing Partner at etera solutions, joined the Steering Committee of the Boston Area CDISC User Network (BACUN), assisting in the planning and coordination of local CDISC-related events. CDISC (the Clinical Data Interchange Standards Consortium) is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. BACUN aims to further the understanding and application of the CDISC standards.

etera solutions displays exhibit at DIA 2008 44th Annual Meeting

Posted by Admin. on: Sunday, June 22, 2008

Etera solutions hosted a booth at the Drug Information Association 2008 44th Annual Meeting in Boston, MA. Over the week, the etera solutions team met hundreds of conference participants, having the chance to discuss industry topics and how the team provides meaningful, practical, cost-effective solutions.

Close

leadership

  • Reed has almost 25 years of SAS programming experience, including 16 years in the Biopharmaceutical industry. He has led, managed, and directed statistical programming, applications, and process improvement groups. He has experience with all manners of Phase I through Phase IV statistical programming support from safety to data management to biostatistics to regulatory to marketing and publications. This work includes writing coding tools, coding edit checks, building analysis datasets, writing code to produce statistical output for clinical reports, developing applications, writing standard policies and procedures, and building eSubmissions. He has knowledge of HL7, ICH, CDISC (SDTM and ADaM) standards and principles, and he has applied them to various projects. Reed holds a Bachelor’s Degree in Mathematics and a Master’s Degree in Liberal Arts.
  • Jeff has over 20 years SAS programming experience in the Biopharmaceutical industry. He has managed statistical programming groups and served as a principal SAS programmer in biotechnology companies and CROs. He has worked in a variety of therapeutic areas including oncology and endocrinology. He has experience with all manners of statistical programming support including data management, providing statistical output for clinical reports, and providing support and guidance for FDA submissions including knowledge of current CDISC (SDTM and ADaM) standards. Jeff holds a Master’s Degree in Biostatistics.
  • Carlo has over 25 years of experience in data management, application development, and statistical programming in the Biopharmaceutical industry. Carlo is versed in both Data Management and Biostatistical Programming, with expertise in process development and compliance. Carlo has served as a manager of CDMS technical staff, and as a Principal Statistical Programmer. In addition he has 14 years of consulting in the Biopharmaceutical industry, during the course of which he architected fit-for-purpose CDMS solutions, lead clinical and statistical programming initiatives, and provided BI solutions to clients.
  • Subbu has 18 years of experience in Information Technology, including 15 years in the Biopharmaceutical industry specializing in CDMS/EDC systems. Having worked with several leading EDC products, Subbu has expertise in the processes and implementation methodologies required to optimize these systems for clients needs and to integrate them with other functional areas. Subbu served as a lead on various EDC initiatives where he focused on implementation, vendor evaluation, developing standards, process development, validation, and deploying studies with CDISC standards. He also served as BI architect on clinical data warehouse. Subbu holds a Master’s Degree in Business Administration and Bachelor’s Degree in Computer Science.
  • Elizabeth has over 20 years of SAS programming experience, including 15 years in the Biopharmaceutical industry. She has managed statistical programming groups and served as a principal SAS programmer in biotechnology companies and CROs. Elizabeth has experience with Phase I through Phase IV statistical programming, as well as data management programming, and she has developed departmental trainings, standards, documentation, and SOPs for statistical programming. Elizabeth holds a Bachelor’s Degree in Economics and Near Eastern History.
  • Arvind has over 15 years of experience in Information Technology, including 13 years in the Biopharmaceutical industry. Arvind’s specialities are process improvement, quality management, and finding simple solutions for complex issues. He has extensive experience in all phases of the software development life cycle and implementation of clinical data management applications. He has led, trained, managed, and directed application development groups using various clinical applications. Arvind holds a Master’s Degree in Computer Science and a Bachelor’s Degree in Computer Science and Engineering.

careers

etera solutions continually adds capabilities in order to serve our clients more effectively. We are actively looking for partners and principals with in-depth Biopharmaceutical industry experience to meet our needs in key areas.

We want team members who are dedicated to excellence in job performance, who truly enjoy communicating and working with others, and who can work at a very fast pace as part of dynamic and knowledgeable teams. We look for expertise in biopharmaceutical clinical development and other related practice areas.

for more info, contact us at

hr@eterasolutions.com