Navigation Links
Spaulding Clinical Announces Strategic Partnership with Clinigene International, India for Providing Comprehensive Early Clinical Solutions to Pharmaceutical and Biotech Clients
Date:8/22/2011

WEST BEND, Wis., Aug. 22, 2011 /PRNewswire/ -- Clinigene International Limited, an India-based Central and Bioanalytical Laboratory and Phase I-IV Clinical Research Organization, and Spaulding Clinical Research, LLC, US-based leading-edge Clinical Pharmacology, Cardiac Core Lab, and Medical Device Manufacturer, announce a strategic partnership agreement.  This partnership establishes a reliable, trustworthy, and cost-efficient global footprint for clinical pharmacology services providing an opportunity for both organizations to engage pharmaceutical clients strategically and accelerate First-In-Human to Proof-of-Concept clinical development.

"Pharmaceutical clients globally are increasingly seeking strategies to expedite their early clinical development, streamlining processes while maintaining high quality.  Our strategic partnership is designed to deliver this in a very cost-effective manner," states Dr. Abhijit Barve, Chief Operating Officer of Clinigene.  "The strengths of both companies are very complementary with Clinigene providing the preclinical development (through sister-company Syngene), Spaulding providing FIH/SAD/MAD, and Clinigene providing DDI and efficient Proof-of-Concept, supported by Clinigene's Central and Bioanalytical Laboratories.  With Clinigene's expertise and cost-effective approach to BA/BE and Spaulding's market-leading TQT study and Cardiac Core Lab expertise, our clients are able to easily structure a program for their compound that  delivers high-value while keeping the molecule knowledge experts involved throughout the entire early clinical development of the compound," states Randol Spaulding, CEO of Spaulding Clinical.

Clinigene operates a CAP-accredited Central Laboratory and GLP-compliant Bioanalytical Laboratory for small and large molecules, both equipped with state-of-art technology, as well as a 94-bed clinical pharmacology unit in Bangalore, India which excels at Bioavailability/Bioequivalence studies, Drug-Drug Interaction and Early Patient Studies.  Spaulding Clinical operates a 105-bed clinical pharmacology unit with 96-beds of Mortara telemetry in West Bend, Wisconsin. The facility is paperless with a phase I Electronic Data Capture system and bi-directional interfaces to safety lab, bedside devices and telemetry.  As a Phase I-IV Cardiac Core Laboratory provider, Spaulding offers the complete suite of equipment provisioning and electrocardiogram over-reading services, including the proprietary Spaulding iQ Electrocardiograph. Both partners have a data solutions team to support clients study data requirements.

Established in 2000, Clinigene (www.clinigeneintl.com) became India's first CAP (College of American Pathologists) accredited Central Laboratory in 2002. Studies conducted at Clinigene's early phase clinic and bioanalytical lab have been inspected by EMEA and US-FDA without Form 483 or critical findings. Clinigene's services now span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs.

Spaulding Clinical Research, LLC (www.spauldingclinical.com) is a leading-edge Clinical Pharmacology, Cardiac Core Lab and Medical Device Manufacturer that offers a full range of global services from study design through study execution/conduct, data management, statistical analysis, and clinical summary/expert reporting.  Spaulding has extensive experience conducting TQT, first-in-human, multiple rising dose, bioavailability/bioequivalence, drug interaction, and food effect studies. As a Phase I - IV Core ECG Laboratory provider, Spaulding offers the complete suite of equipment provisioning and electrocardiogram over-reading services with state-of-the-art technologies and expertly trained cardiologists as well as a revolutionary new ECG device.


'/>"/>
SOURCE Spaulding Clinical Research, LLC
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Spaulding Clinical Welcomes Dr. Aziz Karim, Clinical Pharmacokinetic Consultant
2. Spaulding Clinical Honored at BizTech Conference
3. Spaulding Clinical Announces New Joint Partnership for Global Studies with Eurofins Optimed Clinical Research
4. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
5. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
6. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
7. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
8. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
9. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
10. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
11. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/6/2017)... 2017 ThriveRx, the nutrition division of Diplomat Specialty Infusion Group, ... on nutrition support. To celebrate its anniversary, ThriveRx recently launched ... fresh new look with improved organization to create the best user experience ... ... "We,ve made several great ...
(Date:7/5/2017)... 5, 2017 Oramed Pharmaceuticals Inc. ... ), a clinical-stage pharmaceutical company focused on the development ... received approval from the Israel Securities Authority to dual-list its ... common stock will commence trading on the TASE on July ... market capitalization of the Company, it is expected that Oramed ...
(Date:7/5/2017)... July 5, 2017   BioLife Solutions , Inc. ... and marketer of proprietary clinical grade cell and tissue ... media ("BioLife"), today announced that it has reached an ... and largest shareholder, to modify its existing credit facility ... the modification, WAVI agreed to exchange its existing $4.25 ...
Breaking Medicine Technology:
(Date:7/24/2017)... ... 2017 , ... Every year, thousands of dedicated Higher Education and K12 professionals ... is coupled with a dynamic theme like Camp Canvas; this year, they’ve managed to ... , To extend their partnership with Canvas beyond the LMS integration, Modo Labs ...
(Date:7/24/2017)... ... July 24, 2017 , ... ... organizations that already work hand-in-hand on an Innovation Collaboration program, have signed a ... quality, experience and cost of the care members and patients receive. The agreement ...
(Date:7/24/2017)... ... ... Anyone who uses scales know they have limits; a small kitchen scale ... scale to dispense medication. The first example is an issue of capacity, while the ... important to have the right balance for the process. METTLER TOLEDO’s new white paper, ...
(Date:7/24/2017)... ... July 24, 2017 , ... ... solution focused on delivering end-to-end sleep health care at scale, indicates record-breaking ... shows that adherence rates for positive airway pressure (PAP) therapy, the most widely ...
(Date:7/24/2017)... , ... July 24, 2017 , ... ... received the prestigious StorErotica “Consumer’s Choice” Award, for favorite sex toy. Created in ... 11th annual StorErotica Awards to be consumer voted. The Magic Wand Rechargeable won ...
Breaking Medicine News(10 mins):