Biopharmaceutical Sponsor Interaction with Clinical Site Networks Pulse Report

Sponsor Outsourcing Dollars May Shift to Clinical Site Networks, Transforming the CRO Relationship - February 13, 2024 - Life Science Strategy Group, LLC

Patient Experience and Satisfaction with Electronic Consent, Onboarding, and Diaries in Clinical Trials Report

New Market Research Shows Different Patient Preferences for Electronic Diaries - January 31, 2024 - Life Science Strategy Group, LLC

Johari Digital Healthcare Limited Hosts Successful Webinar on Design for Manufacturing (DFM) for Medical Devices

Johari Digital Healthcare hosted a successful webinar on "Building Cost-effective Medical Devices through Design for Manufacturing." The 60-minute event discussed challenges in balancing cost and product robustness, featuring real-world case studies. Speakers highlighted early DFM benefits, such as cost reduction and faster time-to-market. - January 22, 2024 - Johari Digital Healthcare Ltd.

Impact of the In Vitro Diagnostic Regulation on Clinical Trials in the EU and CRO Outsourcing Report

IVDR Delays Driving Trial Sponsors to Actively Seek Alternative Site and CRO Outsourcing Strategies - January 17, 2024 - Life Science Strategy Group, LLC

ALPCO Announces the Commercial Launch of Its FDA 510(K) Cleared Calprotectin Immunoturbidimetric Assay

American Laboratory Products Company, Ltd. ("ALPCO"), a global provider of specialty diagnostic solutions, proudly announces the commercial launch of its FDA 510(k) cleared Calprotectin Immunoturbidimetric Assay, enhancing its suite of Gastrointestinal (GI) diagnostic solutions. In July... - December 19, 2023 - ALPCO

Johari Digital Healthcare Ltd. Clinches Prestigious "Pharmaceutical & Healthcare MSME of the Year" Award at ET MSME Awards 2023

Johari Digital Healthcare Ltd. has clinched the esteemed "Pharmaceutical & Healthcare MSME of the Year" award at the ET MSME Awards 2023 in New Delhi. Celebrating the resilience of India's MSME sector, the event recognized Johari Digital Healthcare Ltd. for its exceptional contributions to healthcare, particularly in manufacturing and research & development. - December 18, 2023 - Johari Digital Healthcare Ltd.

GeneProof Announces Expansion of Its IVDR-Certified PCR Portfolio

GeneProof, a leader in molecular diagnostics, today announced the addition of six new IVDR-certified PCR kits to its expansive portfolio. This comes as a testament to the company’s dedication to delivering its entire portfolio of approximately 80 products as IVDR compliant by 2027. Currently,... - October 03, 2023 - ALPCO

ALPCO Receives FDA 510(k) Clearance for the Calprotectin Immunoturbidimetric Assay

American Laboratory Products Company, Ltd. ("ALPCO"), a global provider of specialty diagnostic solutions, today announced recent FDA 510(k) clearance of its Calprotectin Immunoturbidimetric Assay. The Calprotectin Immunoturbidimetric (IT) Assay is now IVDD and 510(k)-cleared for in... - June 15, 2023 - ALPCO

New Research Benchmarks Biopharmaceutical Perceptions of Global CRO Thought Leadership

Landmark Research Analyzes Perspectives of US and EU Biopharma C-Suite, Clinical Operations and Medical/Regulatory Affairs Professionals on Global CRO Thought Leadership. - June 01, 2023 - Life Science Strategy Group, LLC

Johari Digital Makes a Significant Contribution from Their CSR Fund to Support Innovation, Research & Incubation at IIT, Jodhpur

As a part of the Industry and Academia collaboration, Johari Digital Healthcare Ltd. donated a significant funding amount to IIT, Jodhpur Incubation & Innovation center from their CSR Fund to boost & strengthen Med-Tech Startup Ecosystem. Mr. Satyendra Johari, Executive Chairman &... - April 24, 2023 - Johari Digital Healthcare Ltd.

Thermo Fisher Partners with ALPCO-GeneProof to Broaden Their CE-IVD Molecular Assay Portfolio

ALPCO-GeneProof, a global leader in diagnostics, and Thermo Fisher announced a strategic partnership that brings the TaqPath Menu | GeneProof PCR kits to market. The partnership combines the strengths of ALPCO-GeneProof’s expertise in molecular diagnostics with Thermo Fisher’s robust... - April 17, 2023 - ALPCO

New Research on Decentralized Clinical Trial (DCT) Strategies to Boost Patient Diversity

Current and Future Clinical Trial Participants Link Enhanced Diversity and Inclusion of Underrepresented Patient Populations to DCT - March 29, 2023 - Life Science Strategy Group, LLC

New Research Identifies Latest Clinical Development and CRO Outsourcing Trends in China

Groundbreaking Research Explores the Chinese Innovative Biopharmaceutical Clinical Development Market, CRO Outsourcing and Future Growth with Over 100 Chinese Biopharma Professionals - March 15, 2023 - Life Science Strategy Group, LLC

Newly Available Horse-Side IgG Test Requires No Refrigeration

Newly Available Horse-Side IgG Test Requires No Refrigeration

VMRD, Inc is excited to share the launch of their latest offering for equine veterinarians, a novel horse-side test to measure IgG in foals. - January 17, 2023 - VMRD, Inc.

Nisha Johari, MD & Co-Founder, JDHL Featured as "Most Influential Business-Woman of the Year 2022"

Mrs Nisha Johari, MD & Co-founder of Johari Digital Healthcare Ltd. has been featured as "The Most Influential Business Women of the Year 2022,” by The CEO Magazine. - December 31, 2022 - Johari Digital Healthcare Ltd.

SYNG Pharmaceuticals Announces Issuance of Its Canadian Patent for Non-Hormonal Therapy for Endometriosis

SYNG Pharmaceuticals Inc. (SYNG), a Kingston, Ontario based women’s health biotech, is pleased to announce that on October 04, 2022, the Canadian Intellectual Property Office granted Canada Patent No. 2,903,608 titled, "Treatment of endometriosis, angiogenesis and/or endometrial lesion growth." - October 09, 2022 - SYNG Pharmaceuticals Inc.

New Decentralized Clinical Trial (DCT) Patient Satisfaction and Participation Report

800 Current and Future Clinical Trial Participants Link Satisfaction and Willingness to Participate with Decentralized Strategies - September 21, 2022 - Life Science Strategy Group, LLC

VMRD Begins Manufacturing Key Reagent for Detection of CWD by RT-QuIC

VMRD Begins Manufacturing Key Reagent for Detection of CWD by RT-QuIC

Veterinary Medical Research & Development (VMRD), Pullman, WA, has partnered with CWD Evolution, Fort Collins, CO, to provide state-of-the-art diagnostic reagents for detection of the abnormal prion associated with Chronic Wasting Disease (CWD). The control of CWD requires identification of... - August 09, 2022 - VMRD, Inc.

American Laboratory Products Company Merges with GeneProof

American Laboratory Products Company, Ltd. (“ALPCO”), a specialty in vitro diagnostics company, today announced a merger with GeneProof a.s. (“GeneProof”), a leading molecular diagnostics company based in Brno, Czech Republic. The combination creates a global market leader... - April 21, 2022 - ALPCO

ALPCO Announced Its Support of the Ukrainian People in a Company-Wide Communication to Its Employees

ALPCO (Salem, NH) announced its support of the Ukrainian people in a company-wide communication to its employees. The message outlined the company's contribution to aid refugees through the American Red Cross and Project Hope in the amount of $5,000 each. Additionally, ALPCO is offering an... - March 16, 2022 - ALPCO

Johari Digital Expands Its Horizons for Better Healthcare

Johari Digital Healthcare Ltd. is glad to announce that Johari Digital is expanding to Medical Device Park, Jodhpur, Rajasthan, India. With the expansion, Johari Digital will triple its capacity to uptake challenging projects. Johari welcomes projects from startups as well as Global Med-Tech companies. - March 04, 2022 - Johari Digital Healthcare Ltd.

MacroArray Diagnostics GmbH (MADx) Partners with ALPCO to Offer a Fully Automated Sample-to-Answer Multiplex Allergy Test Solution to the North American Market

ALPCO (Salem, NH), a leading US producer of novel immunoassay testing platforms, recently announced an exclusive distribution partnership with MacroArray Diagnostics GmbH (Vienna, Austria). Together, they offer a comprehensive line of testing solutions for allergies (IgE-based) and food intolerances (IgG-based), from test material to proprietary hardware and software to process and analyze samples. - February 01, 2022 - ALPCO

Johari Digital Healthcare Inaugurated the "Johari Center of Excellence" in IIT Jodhpur Technology Park

Most research and innovations from Academia end up in publications or are shelved, but now with Industry and academia collaboration it will have chance to get converted into a real product through engineering and transfer to manufacturing cycle along with required regulatory compliances. - January 10, 2022 - Johari Digital Healthcare Ltd.

Updated Findings of COVID-19 Impact on Biopharmaceutical Industry & CRO Outsourcing Report

2021 Survey Quantifies Current and Expected impact of COVID-19 on Clinical Development and CRO Outsourcing and Changes Since 2020 - May 25, 2021 - Life Science Strategy Group, LLC

Erica Cai Named ALPCO’s Summer 2020 Diabetes Research Travel Grant Recipient

Erica Cai Named ALPCO’s Summer 2020 Diabetes Research Travel Grant Recipient

Today ALPCO announced Erica Cai from Harvard Medical School as the latest recipient of its Diabetes Research Travel Grant. Dr. Cai is a postdoctoral fellow from the Joslin Diabetes Center researching the mechanism of autoimmunity that leads to beta cell destruction and type 1 diabetes (T1D). Dr. - November 10, 2020 - ALPCO

3Sixty Pharma Solutions Announces Successful Approval of FDA Investigational New Drug Application

3Sixty Pharma Solutions LLC., www.3sixtypharma.com, has announced the successful submission to FDA, and approval of, an Investigational New Drug (IND) Application on behalf of one of its clinical-stage biotech clients. 3Sixty Pharma Solutions’ 360 Start-Up arm continues to be committed to... - October 15, 2020 - 3Sixty Pharma Solutions

Introducing EDI’s COVID-19 Nucleocapsid IgG Quantitative ELISA Kit

The EDI™ COVID-19 Nucleocapsid IgG Quantitative ELISA Kit is designed, developed & produced for the quantitative measurement of human anti-COVID-19 (anti-SARS-CoV-2) IgG antibody in serum. The test uses a series of calibrators & controls in order to determine a standard curve, which allows for specific, concentration-based results of patient samples, giving researchers & healthcare providers access to quantitative patient data in order to better understand a patient's current disease stage. - October 14, 2020 - Epitope Diagnostics, Inc.

Ampersand Capital Partners Acquires American Laboratory Products Company

American Laboratory Products Company, Ltd. (ALPCO), a specialty in vitro diagnostics company, today announced the majority recapitalization of the company by Ampersand Capital Partners. Ampersand’s investment will be used to support ALPCO’s worldwide growth initiatives, including the... - September 21, 2020 - ALPCO

New eClinical Platform Strategic Analysis & Competitive Landscape Report

Survey Quantifies eClinical Platform Use and Satisfaction and Identifies Dramatic Perceptual Changes - August 26, 2020 - Life Science Strategy Group, LLC

Mountain Country Foods Has Partnered with Immunostics, Inc. to Ensure the Health and Safety of Its Employees Through COVID-10 Antibody Testing

Mountain Country Foods Has Partnered with Immunostics, Inc. to Ensure the Health and Safety of Its Employees Through COVID-10 Antibody Testing

Mountain Country Foods has partnered with Immunostics Inc. and Dr. L Scott Benson of the University of Utah School of Medicine to support and maintain a healthy workforce during the COVID-19 crisis. - May 18, 2020 - Immunostics Inc.

New COVID-19 Impact on Biopharmaceutical Industry & CRO Outsourcing Report

Survey Quantifies Current and Expected impact of COVID-19 on Clinical Development and CRO Outsourcing - April 30, 2020 - Life Science Strategy Group, LLC

Marlena Holter Named ALPCO’s Winter 2020 Diabetes Research Travel Grant Recipient

Marlena Holter Named ALPCO’s Winter 2020 Diabetes Research Travel Grant Recipient

ALPCO's Winter 2020 Diabetes Research Travel Grant has been awarded to Marlena Holter, a DVM/PhD candidate from Cornell University’s College of Veterinary Medicine. Ms. Holter’s novel research focuses on GLP-1 regulated glucose regulation following vertical sleeve gastrectomy surgery to define the mechanisms underlying type 2 diabetes remission and metabolic improvement following bariatric surgery. - April 14, 2020 - ALPCO

Immunostics Launches Two Rapid COVID-19 Ab Test Platforms - AFIAS and iChroma COVID-19 Ab Tests

Immunostics Launches Two Rapid COVID-19 Ab Test Platforms - AFIAS and iChroma COVID-19 Ab Tests

Both AFIAS and iChroma COVID-19 Point-of-Care Tests Detect the Novel Coronavirus within 10 Minutes using a whole blood, serum or plasma sample. - April 13, 2020 - Immunostics Inc.

Epitope Diagnostics Has Proudly Introduced Immunoassay Kits Exclusively for the Qualitative Detection of COVID-19

The EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit and EDI™ Novel Coronavirus COVID-19 IgM ELISA Kits. With proven results from clinical testing in China, Epitope Diagnostics, Inc. is eager to cooperate and collaborate to combat the current COVID-19 situation. - March 06, 2020 - Epitope Diagnostics, Inc.

3Sixty Pharma Solutions Partners with Westchester Biotech Project

3Sixty Pharma Solutions Partners with Westchester Biotech Project

Leveraging its “360Start-Up” Powerhouse to Grow a Dynamic Non-Profit for Scientists - January 11, 2020 - 3Sixty Pharma Solutions

3Sixty Pharma Solutions Announces Successful Submission of Start-Up Biotech Investigational New Drug Application

3Sixty Pharma Solutions LLC, www.3sixtypharma.com, last week announced the successful submission to FDA of its first Investigational New Drug (IND) Application on behalf of one of its start-up biotech clients. This news comes on the heels of the formal organization in 2018 of 3Sixty Pharma... - December 16, 2019 - 3Sixty Pharma Solutions

ALPCO Announces Deadline for Winter 2020 Diabetes Research Travel Grant Award

ALPCO Announces Deadline for Winter 2020 Diabetes Research Travel Grant Award

ALPCO announced the submission deadline for its Winter 2020 Diabetes Research Travel Grant Award. Each recipient is awarded up to $2500 to present their research at a relevant conference and a $2500 product credit. - December 04, 2019 - ALPCO

ALPCO Launches Analytically Specific Human and Rodent STELLUX® Glucagon ELISA

ALPCO Launches Analytically Specific Human and Rodent STELLUX® Glucagon ELISA

ALPCO's new STELLUX® Chemiluminescence Glucagon ELISA features increased analytical specificity and a broad range to accurately quantify glucagon levels between 0.86 and 143.7 pmol/L (3-500 pg/mL) in human and rodent samples. - November 06, 2019 - ALPCO

ALPCO’s New Fecal Calprotectin ELISA with Superior Clinical Accuracy Receives FDA 510(k) Clearance

ALPCO’s New Fecal Calprotectin ELISA with Superior Clinical Accuracy Receives FDA 510(k) Clearance

ALPCO received 510(k) clearance from the US FDA for its new fecal Calprotectin Chemiluminescence ELISA test. The ALPCO Calprotectin Chemiluminescence ELISA’s superior clinical accuracy will enable clinical laboratories to provide the most accurate results to gastroenterologists facing the challenges of differentiating IBD from IBS. - October 30, 2019 - ALPCO

New Research Benchmarks Clinical Investigator Satisfaction with Pharma Sponsors and Central Laboratories

8-year Study Tracks Central Lab Performance and Identifies Covance as Leading the Way in Clinical Investigator Satisfaction. - August 13, 2019 - Life Science Strategy Group, LLC

New Research Benchmarks Pharma’s Changing Utilization of Real-World Evidence (RWE) and Its Impact on Contract Research Organizations (CROs)

Study Tracks Utilization of Real-World Data (RWD), Real-World Evidence (RWE) and Supportive Services and Implications to CROs. - June 11, 2019 - Life Science Strategy Group, LLC

ALPCO Announces January 2019 Young Investigator Award Recipient of Its Diabetes Research Travel Grant

ALPCO Announces January 2019 Young Investigator Award Recipient of Its Diabetes Research Travel Grant

ALPCO awards its January 2019 Diabetes Research Travel Grant to Lisa Volpatti at Massachusetts Institute of Technology. - February 05, 2019 - ALPCO

Immunostics Announces the Availability of the Hemochroma PLUS™

Immunostics Announces the Availability of the Hemochroma PLUS™

FDA 510(k) clearance allows Immunostics to market and sell its new hemoglobin analyzer. - January 23, 2019 - Immunostics Inc.

ALPCO Launches FDA Class I Exempt STELLUX® Glucagon ELISA

ALPCO Launches FDA Class I Exempt STELLUX® Glucagon ELISA

ALPCO announces launch of its new highly specific FDA Class I Exempt STELLUX® Chemi Glucagon ELISA. - October 23, 2018 - ALPCO

Epitope Diagnostics, Inc. Certifies Its Total 25-OH Vitamin D EIA Kit Through the CDC’s Vitamin D Standardization-Certification Program (VDSCP)

Epitope Diagnostics, Inc. (EDI), is pleased to announce it has received certification for the Vitamin D Standardization Program (VDSP) for vitamin D measurement in the EDI™ Total 25-OH Vitamin D EIA Kit. CDC’s Vitamin D Standardization-Certification Program (VDSCP) evaluates the... - October 21, 2018 - Epitope Diagnostics, Inc.

ALPCO Announces Inaugural Young Investigators Award Recipient

ALPCO Announces Inaugural Young Investigators Award Recipient

ALPCO announces the first recipient of its new young investigators award, the Diabetes Research Travel Grant. - October 17, 2018 - ALPCO

ALPCO’s Quality Management System Receives ISO 13485:2016 Certification

ALPCO’s Quality Management System Receives ISO 13485:2016 Certification

ALPCO announces that its quality management system recently received the distinguished ISO 13485:2016 certification from Intertek to ensure the quality, safety and efficacy of its products in the clinical diagnostics field. - October 09, 2018 - ALPCO

Epitope Diagnostics, Inc. Joins MetroConnect to Expand International Growth

Epitope Diagnostics, Inc. is pleased to announce it has been selected to take part in MetroConnect 2018, an export assistance program run by the World Trade Center San Diego (WTC) and designed to help San Diego companies accelerate their global growth. This program will allow Epitope Diagnostics... - September 23, 2018 - Epitope Diagnostics, Inc.

ALPCO to Exhibit at the AACC’s 70th Annual Scientific Meeting and Clinical Lab Expo

ALPCO to Exhibit at the AACC’s 70th Annual Scientific Meeting and Clinical Lab Expo

ALPCO will promote the expansion of its STELLUX® Chemiluminescence ELISA platform, as well as its current therapeutic drug monitoring portfolio, gastroenterology testing panel, and assay qualification program at AACC’s 70th Annual Clinical Lab Expo. - July 25, 2018 - ALPCO

ALPCO and InSphero Partner to Offer a Complete Solution to Assess Beta-cell Function in Islet Microtissue Culture Models

ALPCO and InSphero Partner to Offer a Complete Solution to Assess Beta-cell Function in Islet Microtissue Culture Models

ALPCO and InSphero announce partnership to provide customers with a complete solution to assess beta-cell function in islet microtissue culture models. - July 24, 2018 - ALPCO

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