Guidance Software, Inc. Company Profile

Company Overview:

BioClinica Inc  is a provider of integrated clinical trial management solutions. It offers its products and solutions to pharmaceutical, biotechnology, medical device companies, and contract research organizations (CRO). The company’s products and services include medical image management solutions; electronic data capture (EDC) solutions; clinical data management; clinical trial management systems (CTMS); cardiac safety solutions; and eClinical solutions.

The company offers these solutions to more than 400 pharmaceutical, biotechnology and device companies. The company categorizes its solutions and services into Medical Imaging and Biomarkers, Global Clinical Research and eClinical solutions. The Medical Imaging and Biomarkers solutions segment offers centralized medical imaging services and specialized biomarker services for clinical trials on a broad range of therapeutic areas including oncology, neuroscience, musculoskeletal, cardiovascular, metabolic and endocrinology, inflammatory and gastroenterology, among others.

BioClinica offers global support for clinical trials through its SMART Imaging Services, a comprehensive suite of medical imaging services. It consists of SMART Submit to electronically upload imaging data from clinical trial sites through a web portal; SMART Manage to track all patients enrolled on studies and all imaging data generated during the course of a clinical trial; SMART Analyze independent image review by in-house and contracted radiologists and therapeutic area imaging specialists; SMART Report comprehensive reporting service for sites and sponsors which supports the management and review of data for clinical trials; and SMART Transfer Tools to enable clinical trial data delivery, including patient data and imaging data, to sponsors, external vendors and partners.

BioClinica offers imaging core lab (ICL) solutions that assist clients in the design and management of the medical imaging component of clinical trials for a wide range of modalities including computerized tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), quantitative coronary angiography (QCA), single photon emission computerized tomography (SPECT), dual energy X-ray absorptiometry (DXA/DEXA), intravascular ultrasound, peripheral quantitative angiography, and ultrasound among others.

Bioclinica offers a comprehensive range of digital ECG technology and comprehensive ECG services across all clinical study phases. It offers TQT study support, including concept and protocol design, ECG management and analysis and regulatory reporting. It has scientific expertise and technological capabilities to offer cardiac safety monitoring through a wide range of imaging modalities. It offers WebHeart proprietary platform for the management, processing, analysis and reporting of cardiovascular safety and efficacy data including ECG and hemodynamic endpoints.

Bioclinica Lab offers more than 70 biochemical assays including efficacy biomarkers, predictive biomarkers, and safety biomarkers to help its customers evaluate the therapeutic potential of their investigational compounds in clinical trials and orient their drug development programs. Its major biomarker assays include ELISA, Radioimmunoassays (IRMA, RIACT), ECLIA, CLIA, Colorimetric and Immunoturbidimetric. The company’s Molecular Markers Database System (MMDS) handles clinical trial data, from sample information through data analysis and transfer.

The Global Clinical Research segment further classified into Research Network, Post-Approval Research and Patient Recruitment and Retention divisions. Bioclinica Research Network division simplifies the complexity and solves the challenges associated with clinical trials through a global network of investigator sites.

The Post-Approval Research division designs and executes post-approval research for observational studies, post-marketing commitments, post-approval safety studies and large, simple trials. The Patient Recruitment and Retention division locates, engages, and retains patients for clinical trials by maintaining an extensive and dynamic patient database and multi-faceted patient communities. The eHealth solutions segment consists of three major offerings: eClinical solutions, Safety and regulatory solutions and Financial lifecycle solutions.

The eClinical solutions include Express EDC, Trident RTSM, Optimizer, OnPoint CTMS, App xChange, eHealth Cloud and Compass. The Safety and Regulatory Solutions include drug safety and pharmacovigilance services to small, mid and large sized pharmaceutical and biotechnology companies; drug safety technologies including LitTrace customizable literature monitoring and tracking tool, SigTrace consolidated, end-to-end signal management tool and PVTrace customizable pharmacovigilance process management tool; and Regulatory affairs services and IT services including enterprise solutions and consulting services.

Bioclinica started offering Financial Lifecycle Solutions through the acquisition of Clinverse, Inc. It manages the global automation and financial management of clinical trials. The company also has application hosting and support capabilities. It operates 23 dedicated research centers in 14 countries. BioClinica sells its products through direct sales force and through relationships with CROs. The company has its own sales forces in the US and European markets.

Scope of the Report

• About the Company - Historical Details, Current Ownership Structure and basic overview of Guidance Software, Inc. in terms of revenue, net income, and operating income.
• Financials - Details about Guidance Software, Inc. listing status, annual financial reports (for the past 5 years), key financial highlights and region wise and category wise breakdown of their net revenue.
• Products / Services - Listing of the company’s entire portfolio along with description of individual products / services providing a clear picture of their target audience.
• Company SWOT Analysis - Outlines Guidance Software, Inc.’s strengths, weaknesses, and opportunities and threats facing the company.
• Recent Developments - Showcases Guidance Software, Inc.’s recent developments including mergers, acquisitions, partnerships, collaborations, new product launches, investment and divestment plans.
• Strategic Evaluation - Provides an overview of Guidance Software, Inc.’s corporate goals and strategic initiatives and evaluates their outcomes along with outlining any persisting legal issues and outlook of our in-house analyst panel on the particular company.
• Technology Landscape - Details how the company allocates its IT budget across the core areas of its business, CIO/CTO Profile, Key IT Initiatives and Deals undertaken buy the company at present along with outlook.

Key Questions Answered

• What domain does Guidance Software, Inc. operate and what are key points about it?
• What is the product / service portfolio of Guidance Software, Inc.?
• How has Guidance Software, Inc. performed financially from the 2013?
• How does Guidance Software, Inc. rank among its peers in terms of revenue and market share?
• What are Guidance Software, Inc. strengths and weaknesses and what opportunities and threats does it face?
• What are Guidance Software, Inc.’s main growth strategies and how successful has the company been at implementing them?
• What is the in-house technical capability of Guidance Software, Inc.? Where does it procure / outsource it?

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