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Clinical Pharmacovigilance

    
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Allphase Clinical Research  Allphase Clinical Research is a clinical stage full-service Contract Research Organization (CRO) specializing in Respiratory, Oncology, Cardiovascular and CNS. Over the last 12 years we have run over 150 trials for small...
 
Clinical Pharmacovigilance Diligent medical oversight is essential to ensure the protection of study patients, and ultimately the safe use of new products as they reach the market....
Myriad RBM, Inc.  Myriad RBM is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from preclinical through Phase...
 
Services Provided Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its...
BASi - Bioanalytical Systems, Inc.  bioanalytical sample analysis automated in-vivo blood sampling toxicology pharmaceutical analysis electrochemistry EC liquid chromatography LC Vetronics
 
Pharmaceutical Analysis Contract Services BASi scientists can provide support for all phases of your drug development, from early stage preclinical method development/sample analysis to...
Fortitude Clinical  Fortitude Clinical. Clinical Research Organisation (CRO), Site Management Organisation (SMO), and Generic Product Services in Asia Pacific. Headquartered in Singapore.
ITClinical  Pharmacovigilance Software, Clinical Trial Management, Technical Translations, Scientific Consulting, EDC, IWRS
 
Pharmacovigilance Software The Pharmacovigilance System is a Software that offers the capability to manage the pharmacovigilance activities related with suspected Adverse Drug...
Novella Clinical  Novella Clinical is a full service clinical research organization dedicated to clients in the oncology, medical device and biopharmaceutical industries. For over a decade Novella has served as a trusted outsourcing...
 
Oncology Expertise Prologue Research provides a full range of clinical trial services – from protocol design to FDA submission – in order to speed your drug or device to...
RUSSLAN Clinical Research, CRO  RUSSLAN Clinical Research is an independent European clinical trial management organisation offering a range of clinical research services to worldwide clients in the pharmaceutical, biotechnology and medical device...
KAI Research, Inc  Full service CRO specializing in clinical trial and data management, clinical safety, pharmacovigilance, QA, statistical analysis and regulatory affairs
 
ARISg Safety System ARISG drug safety and reporting system. State of the art commercial system for reporting adverse events. Capable of electronic submissions to the FDA and...
 
OpenClinica Enterprise OpenClinica Enterprise EDC complies with 21 CFR Part 11 requirements and allows rapid startup of studies, extensive editing, Web based query tracking and...
PrimeVigilance Ltd  Compliant and professional, PrimeVigilance offers pharmacovigilance services from one-off PSURs to full outsourcing of your pharmacovigilance requirements
Worldwide Clinical Trials, Inc.  Worldwide Clinical Trials is a global CRO that provides full-service drug development services to the pharmaceutical and biotechnology industries. As one of the most innovative and scientifically-driven contract...
 
Services While Worldwide Clinical Trials supports you in your pre-registration through peri-approval studies, our sister division, Worldwide Clinical Trials Drug...
SGS Life Science Services - Clinical Research  SGS Life Science Services has over 35 years of experience as a global contract service organization providing integrated solutions from preclinical activities to Phase I-IV clinical trials, and bioanalysis.
 
Pharmacovigilance & Medical Affairs Pharmacovigilance and Clinical Safety Solutions
Theorem Clinical Research  Established in 1985, Theorem Clinical Research is one of the industry’s leading full-service, global CROs. Theorem provides core CRO services for Phases I to IV, but with niche business units in the areas of Technical...
 
Early Phase Clinical Trials Whether your project is standard or complex, our Early Phase Business Unit (Phase I/IIa) has a dedicated, streamlined approach that helps ensure we complete...
 
Late Phase Clinical Trials Your drug received approval and is now on the market. But that doesn't mean the clinical development process is over. In fact, Late Phase (Phase IIIb/IV)...
Veeda Clinical Research  Veeda Biometrics is dedicated to providing biometrics services internationally for pharmaceutical, biotech and medical device companies. With offices in Europe and India, Veeda Biometrics is in an unparalleled position to...
 
Clinical Services Veeda Oncology® can provide global pharmacovigilance/surveillance to assist in the development of new oncology therapies. Our safety team is experienced in...
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Clinical Pharmacovigilance - Product Reviews

Pharmacovigilance key to increasing public trust in pharmaceutical industry: SaaS makes software available to all companies 

The benefit of pharmacovigilance to the reputation of drug development and marketing concerns is well known. Pharmacovigilance, which underpins government regulations, has become even more important as globalization requires a unified world-wide set of regulations.  
Currently, only large companies have their own pharmacovigilance systems. Upcoming regulations, like the FDA’s electronic submission requirement that comes into effect in 2010, will necessitate that small to mid-size companies also use these systems. Most smaller companies do not have the budget to purchase this expensive software application, and to add data-entry employees to their staff, in addition to the personnel needed to implement and maintain the system.

SaaS provides a way for these smaller players to be able to both afford the use of a pharmacovigilance system and to have access to the same software as large corporations. Companies who already have systems can choose to only outsource data input and maintenance. Outsourcing of pharmacovigilance is beneficial to companies for another reason. Michael Reynolds, head of sales and marketing at APCER Pharma, points out that outsourcing pharmacovigilance work “enables the company not only to do its ‘real’ job – bringing new therapies to market – but also to do it efficiently with good, clean, validated data.”
 

Best-in-Class Clinical Pharmacovigilance Services Providers:

  • Ability to perform both contextual single case evaluations as well as case-series analyses
  • Performs statistical proportionality and correlation checks
  • Has add-ons for the electronic reporting of adverse events


Top Considerations Before Selecting Clinical Pharmacovigilance Services Provider:
If your company already has an in-house pharmacovigilance system, and you are planning on only outsourcing the day-to-day administration, be sure to choose a vendor who runs the same system or has had experience with your type of system. Pick a vendor whose software systems are versatile enough to allow you to have different levels of input from nil to full access as the situation changes.


Key Producers:

1. CLIA-certified Rules-Based Medicine, Inc. (RBM) markets biomarkers for clinical pharmacovigilance testing and other purposes. RBM’s solutions include a self-contained whole-blood culture system for ex vivo immune response measurement and therapeutic-specific MAPs custom designed for late-stage clinical development. RBM's tests, which have been validated to meet or exceed clinical laboratory standards,  allow extension of the reproducible biomarker pattern discoveries made in the pre-clinical stage forward into human clinical trial stage. Corporate headquarters and CLIA-certified biomarker testing laboratory are in Austin, TX; multiplex assay development and manufacturing is in Lake Placid, NY and a subsidiary unit is located in Germany. RBM, founded in 1998, is the world's leading biomarker testing laboratory.

2. The Jackson Laboratory offers state-of-the-art facilities, research support and a wide range of technologies, as well as mice colonies, to organizations around the world engaged in clinical pharmacovigilance studies.  This company, which was started in 1929 as one of the first centers for cancer genetics research, is a major provider of genetic resources, software, and expertise to the scientific community. Its extensive experience with experimental genetics enhances the services it offers. This independent, non-profit laboratory has two facilities in Maine and California and plans for a third in Florida, which will be funded by the state. The Jackson Laboratory also advances science by offering academic programs for teachers and students as well as for corporate researchers.

3. Aris Global is a global provider of consultancy services including drug safety, drug safety monitoring, pharmacovigilance, regulatory compliance, medical information and R&D and clinical trials management software. It reports that “more than 300 life sciences companies and CROs in countries around the world use Aris Global’s Total Safety — a comprehensive suite of integrated software solutions that enable life science organizations, regardless of status or size, to implement effective domestic and global pharmacovigilance, clinical safety, Signal detection and risk management programs.” This Stamford, Connecticut-headquartered company was founded in 1987.

4. BioSoteria provides a broad range of pharmacovigilance solutions and individually tailored services to the biopharmaceutical industry. Safety services range from an a la carte safety solution to serving as a fully functional safety department. It also has drug safety training and educational programs. BioSoteria reports that its management team "has experience building drug safety departments from the ground up at start-up companies and expanding pharmacovigilance capabilities for larger companies." This company has decades of experience and has offices in California and North Carolina. 

Clinical Pharmacovigilance Services
Definition: Pharmacovigilance (PV or PhV) is the pharmacological science relating to the detection, assessment, understanding and prevention of the adverse long and short term side

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Clinical Pharmacovigilance Research Library

Determination of an Acceptable Preservative for...
BASi - Bioanalytical Systems, Inc.
This method uses a 50:50 THF:water extraction solvent for the preparation of standards and samples. Preservative at a level of 0.1 weight percent in solution was added to stabilize the preparations. Analysis was accomplished by HPLC carried out on a Phenomenex Luna Phenyl Hexyl (150 x 4.6 mm) column at a flow rate of 1.0 mL/min. The separation was completed with a mobile phase of 35 mM ...
 
Allphase Clinical - Risky Business
Allphase Clinical Research
Executing a clinical development program without sufficient resources, experience, and planning is akin to starting a war armed with a pea-shooter. This is a trend that has been developing during these recession plagued years. Despite the counter-intuitiveness of the approach, one can sympathize given the incessant ticking of the patent clock and the difficulties in securing and maintaining ...
 
An Overview of Assay Quality Systems at Rules-Based Medicine
Myriad RBM, Inc.
Stringent guidelines of quality assurance and control (QA/QC) serve as the foundation for dependable and reproducible results in any analytical endeavor. Read step-by-step how the RBM platform combines the sensitivity and dynamic range of microsphere based immuno-multiplexing with the precision and dependability of automated liquid handling.
 
Thalidomide Tragedy Revisited - An Interview with Dr Vijay
Oviya MedSafe Pvt Ltd
The unforgettable disaster of the Thalidomide Tragedy of the1960’s is arguably one of the largest catastrophes recorded in the history of drug discovery. Fifty years after this calamity the global pharma scenario has undergone a radical transition today. The regulatory norms starting from manufacturing of the drugs, carrying out their clinical trials to approving them for their launch, the pharma ...
 
Legislative Changes to EU Pharmacovigilance System
SGS Life Science Services - Clinical Research
The European Commission announced its intention to introduce the most significant re-design of the EU's Pharmacovigilance (PV) system in the last 40 years. Following a recent public consultation, the Commission aims to significantly strengthen and rationalize the system, in order to make it appropriate for an enlarged EU with innovative products, modern information technology and study designs.
 

Clinical Pharmacovigilance Video

Integrating Siebel Clinical with Oracle Clinical and Remote Data Capture BioPharm Systems, Inc. Param Singh, Vice President of Clinical Trial Management Solutions, discusses integrating a custom configuration of Siebel CTMS with Oracle Clinical and ...
 
The Benefits of Siebel Clinical Integration BioPharm Systems, Inc. You've implemented state-of-the-art enterprise systems for different work functions, but they don't talk to each other. Now what? Savvy organizations know ...
 
Clinical Pharmacovigilance Myriad RBM, Inc. Company

Clinical Pharmacovigilance News

Clinical Pharmacovigilance BASi - Bioanalytical Systems, Inc. Information
Clinical Pharmacovigilance Aptalis Pharmaceutical Technologies Products
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