View white papers from other Pharmaceutical sectors:
1-15 of 50 results
Efficient Drug Registration Process Based on Document Management
In today’s extremely complicated regulatory environment, which is becoming even more complicated by the hour, it is no longer possible to meet challenges of tomorrow with yesterday’s tools. Mountains of paper, the brand of every regulatory affairs department for so long, are bound to disappear. In the new, mostly electronic environment, the quality of a software solution will increasingly become the comparative advantage on the drugs’ long journey from an idea to the market.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
EDMS Based Development Documentation: Decreased Time to Market
Processes in pharmaceutical development departments are mostly serving drug development projects. Documents resulting from these processes normally describe the process milestones. By means of applying the right set of attributes to each document, project management and reporting could be made much easier and less time-consuming.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
EDMS Based QA/QC Documentation: the Lasting Answer to GxP Challenges
In all GxP areas, document handling is one of the most exposed areas when it comes to regulatory inspections. While good document management system cannot by itself ensure the favourable result of an inspection, the lack of it is almost sure to ruin the company’s high expectations, even if there is nothing essentially wrong with the presented data. In order to deal with all the documentation pertinent to the challenges in GxP environment, INFOTEHNA developed QualityExpert. QualityExpert is the solution based on INFOTEHNA proprietary application myProcess, which ensures the compliance with all regulatory requirements, including 21CFR11. In addition, myProcess is the base for all other INFOTEHNA myPharmaExpert Suite solutions, which ensures 100% cross-solution compatibility.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
Efficient Pharmacovigilance Process Based on Document Management
Each company has to establish a pharmacovigilance system, with the primary aim of ensuring timely gathering, analyzing and submission of safety concerns. This documentation is the primary target for any pharmacovigilance audit and thus has to be maintained in a way similar to GMP documentation.
INFOTEHNA solution provides profiles for all of the necessary documents, with predetermined templates, lifecycles, workflows and roles.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
State and Federal “Sunshine Acts” Shift KOL Marketing Tactics
Historically, biological, pharmaceutical and medical device firms ("firms") marketed products to health care providers ("provider") through the provision of clinical information as well as a variety of promotional marketing programs which included various incentives such as free meals, free trips, free CME, free office supplies, honoraria, speaker fees, paid consulting agreements, etc., ("remuneration"). Undisclosed paid endorsements of firm products by key opinion leader (KOL) physicians at academic research institutions arguably resulted in inefficient utilization of products with concomitant resulting financial and/clinical harms to payers and patients. By making such remuneration "transparent", regulators will be able to identify and prosecute abusive and/or illegal remuneration practices by firms and academic KOLs will arguably be more likely to abide by applicable conflict of interest policies.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
Accountable Care Organization Clinical Integration
Since its formation in 1965, Medicare has been the proverbial government manipulated “tail that wags the (private sector health care market) dog” in national health care reimbursement policy. Due to its sheer size and reach, Medicare (Parts A to D) dwarfs all other federal and state healthcare programs combined. Therefore changes affecting Medicare reimbursement and care delivery structure generally have had an immediate, profound, and transformative effect not just on Medicare, but also on private sector commercial insurance reimbursement practices as well. In this sense, Medicare has operated as a government run “incubator” for national healthcare reimbursement policies and structural market reforms. So in order to understand how healthcare has evolved to its present state, one also needs to understand how Medicare has and continues to transform the commercial healthcare industry.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
ALSCG Optimizing Your Return on Investment
Life science organizations are turning to technology to address the shifting challenges of contract management, particularly with respect to controlling potential revenue leakage, safe‐guarding against compliance issues, and facilitating government reporting. Contemporary contract management solutions offer flexible and configurable capabilities that aid in harmonizing pricing guidelines and terms.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
Outsourcing Your Compliance Headache ‐ BPO
Now that the complexities and operational challenges associated with healthcare reform have been recognized, and the life sciences industry gains more clarity around the regulations, many firms are taking time to review their internal infrastructures against government compliance requirements.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
ALSCG Revenue Contract Management System Implementations
A multitude of business drivers are leading Life Sciences companies to evaluate and implement Revenue Contract Management (RCM) solutions. These include the need to ensure compliance in an ever‐changing regulatory landscape, a systematic approach to commercial and government contract administration and the need for business intelligence required to effectively evaluate and implement innovative contracting strategies.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
Staying Compliant with the Physician Payments Sunshine Act
Eleven months after the Patient Protection and Affordable Care Act (PPACA) became law on March 23, 2010, the implementation challenges associated with health care reform continue. Unfortunately for the life sciences industry, the passage of PPACA’s Physician Payments Sunshine Act provisions did not standardize, curtail, or rationalize pre-existing state-specific aggregate spend reporting obligations.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
Healthcare Reform, Compliance, and Organizational Optimization
As the US healthcare industry continues to mobilize with the arrival of the Patient Protection and Affordable Care Act (PPACA), life sciences manufacturers must not only prepare to comply with changing Federal legislation, but also consider how the process of compliance can best be leveraged to optimize their businesses.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
Leveraging CLM Automation for Competitive Advantage
While many organizations have come to realize the importance of implementing more robust contract lifecycle management (CLM) solutions, many fail to realize the full potential benefits of such automation.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
A Powerful and Cost Effective Solution for Today's Research Laboratory
A Powerful and Cost Effective Solution for Today's Research Laboratory addresses how choosing an Accuri C6 Flow Cytometer is a cost effective choice for the research laboratory, not only at the time of instrument purchase but for the entire life of the system
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
Accuri Revolutionizes Flow Cytometry
Accuri Revolutionizes Flow Cytometry addresses how Accuri can sell a high performance flow cytometer for a fraction of the price of existing systems and illustrates the company's approach to product development.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers
Beyond Markush – Protecting Activity not Chemical Structure
By providing a more accurate and useful representation of the activity and properties of compounds, field-based systems have the potential for widespread use in patent applications, taking their place alongside, and possibly in time replacing, Markush structures.
Automation > IT & Software > White Papers
Automation > IT & Software > White Papers