Why Regulatory Services Are Important In Clinical Trials?

Pharmaceutical and the clinical trial industry are the most regulated amidst all other industry verticals. Therefore, every drug priority to attaining market approval needs to undergo strict scrutiny and clinical trials. This ensures its efficacy, safety and quality. These standards of scrutiny and assessment are generally established by regulatory authorities of their respective countries, for instance Medicine Control Agency (MCA) in UK, Drug Controlling Authority (DCA) in India, FDA in US and many more.


The monitoring practices by the pharmaceutical regulatory authorities continue even after the drug has been sanctioned post the clinical trials and marketed in order to detect whether there is any harmful side effect when used by the mass. Clinical regulatory services and policies therefore, have a crucial role to play in catering to the regulatory standards. These services cover the activities which help to create evidence that proves that a medical drug is safe and it meets the legal standards, thereby ensuring good health of the people at large,


Clinical regulatory services help in drug development procedures from clinical trials, marketing phase to post approval practices. It acts as a primary link between the company and the regulatory agencies. A regulatory service professional is accountable for keeping up pace with the increasing complexity as well as the scope of the regulatory policies and services. They act as the main interpreters of law and regulation for other members.


Regulatory services along with quality assurance form an integral aspect of the entire service portfolio in most clinical research organizations (CRO) today. There is a specialized team dedicated to regulatory services and audit compliance that are in turn supported by an in-depth clinical know-how of the local regulatory processes and meaningful alliance with multiple regulatory agencies, making sure there is efficiency in the clinical trial approval process. The service portfolio comprises the following:


* Formulating regulatory strategies

* Compiling clinical trial applications

* Managing the submission and follow-up of the clinical trial application

* Responding to regulatory agency enquiries

* Procuring drug import licenses

* Safety reporting

* Tracking approvals and applications

* Renewing the Import licenses

* Managing the submission of the Clinical Safety Report (CSR)

* Procuring NOC for the export of biological samples


Today the regulatory service department in most Indian CRO’s has the experience of multiple audits of the Indian and global regulatory agencies. They also have experience in making study submissions to various countries and have been approved for the same in places such as in MOH Israel, NPCB Malaysia and National Medicines & Poisons Board, Republic of Sudan.


Read More About: Biometrics Companies, Bioavailability, Clinical Pharmacokinetic

High-End Biometrics Service Portfolio

Biometrics are also described as biometric authentication and includes processes for recognizing humans related to one or more inherent behavioral traits. The traits on which the Biometrics principle’s operates can be divided into two main divisions. They are:


* Physiological - This is associated with the shape of the body, for instance face recognition, palm print, fingerprint, DNA, Iris recognition, hand geometry and many more.

* Behavior – This is related to an individual’s behavior, such as the typing style, gait, voice quality, accent and many more. Certain researchers have also termed this category as behaviometrics.


Clinical Research Organizations (CRO) in India have a systematic and organized Biometrics team that is expert to help clients at several stages of Clinical trials and researches. They support their clients with the time tested technologies and expertise to set up analysis processes, interpretations, study designs and provide support to the overall clinical development program. The expert groups are also backed up by high-end software application that compresses SAS and Win Online.


Indian CRO’s also provide a comprehensive range of Data Management services in the bio-equivalence and Phase I studies. Their objective is to convert raw data to precise and reliable trial outputs complying with the regulatory rules. The clinical development programs in the CRO’s focus on the speed of the regulatory submission procedures and lessen the timeline with the assistance of advanced thinking and quality service. There are multiple categories of Biometrics, such as:


Data Management


* Data Acquisition

* Data Reconciliation

* Discrepancy Management

* Medical Coding (MeDRA & WHODD)

* Database Lock

* Data Extraction for Reporting


Database Programming


* CRF Design (paper & electronic)

* CRF Annotation

* Database Programming

* Validation Checks

* Metadata Repository Management


Biostatistics


* Randomization

* Sample size estimation

* Trial Design Inputs

* Statistical Analysis Plan

* Statistical Analysis

* Biostatistics Subject Matter Expert


Pharmacokinetic & Pharmacodynamic Studies


* Sampling Point Estimation

* Technical Document Review

* PK/PD Query Resolution

* PK/PD Subject Matter Expert

* Clinical Pharmacokinetic support across study engagement


PK/PD Reporting


* SDMS Data Extraction

* PK Data Analysis

* PK Summary Reporting


Statistical Reporting


* TLF Programming

* CDISC Data Mapping (SDTM & ADaM)

* Clinical Data Repository

* Pooled Data Analysis & Reporting

* Safety (ADR) Reporting

* Patient Profiles & Data Cleaning Reporting


Biometrics services provided by well known Indian CRO’s also have the capacity to manage Phase I to IV clinical trials for domestic and international needs in multiple therapeutic areas. This apart, Biometric services are used by multiple pharmaceutical, biotechnology, diagnostics and research organizations.


Read More About: Biometrics Companies, Regulatory Services, Bioavailability, Clinical Pharmacokinetic

Clinical Trial Development in India

The modern changing lifestyle and its chronic ailments are the principal reasons why we need better medications and treatment processes. This is the reason why medical institutions and clinics must give importance to clinical trials and medical researchers to come with advanced drug development processes and innovative treatments.


The Indian subcontinent over the past few years has recorded a quick and steady expansion in the domain of Clinical Trials. This itself proves that India is fast becoming one of the most desired destinations for medical research and advanced clinical studies. As the number of applications for research and study is rising, clinical trials and researches too are expected to increase in the forthcoming years. According to a report on “Booming Clinical Trials Market in India”, the expansion of clinical studies by domestic and international medical institutions has gone up in the recent times. Due to this progress, clinical trials in India are expected to touch the mark of 1950 by 2013. One of the important reasons for this expansion is the upsurge of the industry-sponsored trials that are an important aspect of clinical trials. Apart from this, few other factors such as stable medical architecture and skilled professionals will also improve the percentage of forthcoming medical trials in India.


Recently, there have been various Clinical Research Organizations (CRO) in India that conducts clinical trials, especially focusing on the Phase I studies. Therefore, they have strategic liaisons with reputed hospitals, clinics and medical institutions. This ensures that the CRO also have the access to vast databases that spans across multiple therapeutic areas to other proprietary therapies and diagnostics.


The majority of Indian CRO’s has their own research programs that execute the advanced and innovative new age study designs in Pharmacokinetic analysis, clinical pharmacology, and bio-analytical processes that are carried out by a team of expert and experienced clinical coordinators and research associates. Furthermore, they generally adopt a 360 degree approach towards clinical trials that make sure that the sponsors actually benefit from a host of services such as:


* Pharmacy Services that assures a strict adherence to GCP and other allied international regulatory requirements

* Feasibility Studies

* Clinical Trial Supplies & Management

* Bio Statistics

* Project Management

* Clinical Monitoring

* Volunteer Recruitment & Planning


Indian CRO’s in addition to Clinical Trials also focuses on Bio studies. This comprises multiple studies on bioavailability and bioequivalence are carried out in multiple centers staying in compliance with international regulatory needs managed efficiently by an independent quality assurance section.


Read More About: Biometrics, Regulatory Services, Clinical Pharmacokinetic

Run Applications on Multiple Operating Systems with Cross OS Development Platform

Today’s computing world comprises of heterogeneous computer systems, operating systems and interface environments. The explosion in the number of devices and the difficulty associated with code maintenance has forced programmers to dismiss the initial approach of developing platform dependent applications. Considering the cost, maintenance and marketing issues, programmers are favoring Cross-OS Development Platform that refers to the creation of a single software application that can run on different OS platforms without the expense and delay of “porting” the application code to additional operating systems.


Wikipedia defines cross platform as “an attribute conferred to computer software or computing methods and concepts that are implemented and inter-operate on multiple computer platforms.” Let’s look at some of the advantages of developing software that can run on multiple operating systems.


* Protects your software investment from OS platform changes

* Allows you to easily move your application to a new OS platform

* Minimizes the learning associated with adopting a new operating system

* Reduces the risk associated with choosing an operating system


For any developer, maintaining separate sets of source code for the same application is a difficult but a required task if the application is to run on more than one operating system. With Cross-OS development Platform, developers can eliminate the need to maintain a separate code base, since it facilitates running embedded applications on many real-time operating systems (RTOS). The cross OS development platform is a C/C++ source-level virtualization technology that provides a robust and industry standard OS interface architecture for flexible real-time application development, while allowing the user to protect the software from being locked to a single operating system. Some of the advantages of the cross OS development platform are:


* Eliminates the costs associated with multiple code bases required for multiple OS platforms

* Easily extended to support your proprietary OS

* Eliminates time consuming manual updates to applications when upgrading OS

* Negates future porting issues when your platform changes as the software supports multiple operating systems and versions from the beginning

* Eliminates the risk associated with the OS selection process, since the same application can be tested on multiple platforms for comparison and won’t be tied to the chosen OS

* Common Development Environment for development, porting, virtualization, simulation and testing of applications  (AppCOE )


Thus, there are a number of solid benefits from including cross OS development platform with your application development. It is always difficult to choose the right OS for your project, with Cross-OS Development Platform, the choice is much easier.


Related Links: ada to c, system simulation

Reasons to Change or Upgrade your Embedded OS

There are numerous reasons to port your embedded software application to a new operating system. Some products have been in existence for more than a decade running on the same outdated operating system, other products are much newer but there is a serious question whether the OS manufacturer will maintain the operating system because they have other priorities. There are a host of reasons to consider changing your embedded operating system. Here are a few to think about:


* In 1999, WindRiver Inc. acquired Integrated Systems Inc. After the acquisition was complete, ISI’s pSOS operating system was discontinued. It’s probably safe to say that any manufacturer with a product still running on the pSOS operating system should consider updating their operating system.


* In 2002, Mentor Graphics acquired Accelerated Technology. Accelerated Technology’s Nucleus operating system is still sold by Mentor Graphics but Mentor has moved toward Android and Embedded Linux solutions with Mentor’s purchase of Embedded Alley in 2009.


* In 2010, Research in Motion (RIM) acquired QNX. Since RIM’s primary focus is cell-phones, one might question the level of resources that RIM will dedicate to maintaining and upgrading the QNX operating system.


* Cost – If your product is produced in high volume, moving the application to a royalty free operating system makes a lot of sense. Notice that Android (which is a Linux variation released by Google) has captured over 70% of the smartphone market.


Regardless of the reason, upgrading or changing operating systems is usually not easy. There are a lot of questions to be addressed and work to be done. However, today experienced OS service providers have come up with a porting kit that makes changing to a modern OS easy and quick. The porting kit is a C/C++ source-level virtualization technology that enables software developers to reuse their software developed for VxWorks, pSOS, Linux/POSIX, Windows, Nucleus and μITRON on another OS easily.  This saves money, time, porting labor, and offers superior performance while lessening the time to market.


For those who want to upgrade their existing OS without changing OS vendors, there is an OS Version kit that enables applications to easily upgrade to the new OS version, without manual porting. Available OS Version kits are for:


* LynxOS, LynxOS-178 and LynxOS-SE

* Linux and RT Linux

* Unix and Solaris


Making your present software program adapt to a new OS can be an error-prone and is a laborious process. However, with Porting and OS version kits that are available today, software developers have the choice to move to a new, modern operating system that can support their future needs. This way, they can leverage their present embedded software investment and avert expensive porting concerns in the future.


Related Links: Cross-platform Development in C , ada to c

Counterfeiting – A Major Threat to the Brands

Technological innovations over the years have helped enterprises to expand globally. However, with an objective of earning greater revenue, the enterprise change their marketing strategies, increases their efficiency levels or works towards cutting costs. Further to withstand the competition prevalent in the business environment, enterprises need to meet the customer requirements too. The ever growing and ever-changing customer requirements have paved way to the counterfeit markets.


Counterfeiting means to imitate something. Wikipedia  refers to counterfeit products as “fake replicas of the real product and  describes the forgeries of currency and documents, as well as the imitations of works of art, toys, clothing, software, pharmaceuticals, watches, electronics, handbags and shoes”.  Produced to take advantage of the superior value of the imitated product, the counterfeit products has a fake company logos and brands and results in patent infringement or trademark infringement.


Fueled by consumer demands, counterfeiting today has become a big business with the global trade in illegitimate goods having increased from $5.5 billion to approximately $600 billion annually as per the reports of International Anti counterfeiting Coalition. Other facts surfaced from their report states that approximately 5%-7% of the world trade are in counterfeit goods and the U.S. Enterprises suffer $9 billion in trade losses due to international copyright piracy. Counterfeiting has turned in  as one of the fastest growing economic crimes worldwide threatening the economies of developed and developing countries while damaging  new investment and  endangering  public health and safety.


The technological advancements have further enabled counterfeiters to produce better copies of products and packaging. The increased sales of counterfeit goods have a deep negative impact of the brand reputation. Enterprises thus need to take in adequate steps towards brand protection. One way is to bring in awareness among the consumers about counterfeit products and their impact on the society at large. The consumers who go in for counterfeit products need to understand that by purchasing these counterfeit goods they are risk funding nefarious activities that contributes  to unemployment,  budget deficits thus  compromising the future of the country and global economy.


Understanding the fact that today's counterfeiters are well-equipped and skilled, the leading service providers offer global enterprise anti-counterfeiting solutions that are not only intelligent and intuitive but also one that spans across the enterprise. With a cohesive anti-counterfeiting strategy, these enterprises can work on brand protection through


* Trademark protection with the help of in-house or contractual Intellectual Property lawyers and confiscating of counterfeit goods

* Working with trade groups that share the same common interests can help to efficiently protect the  intellectual property

* With anti-counterfeiting solutions that include global monitoring of e- commerce along with a provision for a back-end database that can organize the collected information into actionable intelligence.


Such solutions that are offered as software-as-a service, provides ways and means to encounter the counterfeiting issues with end-to-end brand protection and real-time monitoring of the sources.


Read More About: Enterprise Risk Management, Gray Market

Combat Gray Market Sales Today

Rapid and innovative development in the internet technology have played in an essential role in flourishing e Commerce and online shopping sites. There are times when you come across online deals with attractive discounts and offer prices. Though it all seems lucrative at the first glance, but there is a high chance of these products being duplicated by unapproved channels and sold at a lesser or higher price. Hence, there is no guarantee that these products and their prices are authentic. The internet today has given rise to gray market or parallel markets that sells faulty goods.


Defining Gray Market


The term “gray market” can be used in multiple ways. The two primary usages of this term indicate a market for legal goods that is carried on in a manner that is not intended by the original manufacturer of the goods. Generally, by itself gray market is not an illegal domain, and neither the products purchased. However, it is highly unregulated and this it can lead to concerns for customers who buy goods from the gray market channels.


For the consumers who are expecting authentic products and authentic manufacturer’s warranty will be upset by gray market sales. Owing to the fact that is it disorganized and the channels are not approved by original manufacturers there is a chance of faulty goods or duplicated goods entering the market. This in turn results in customer dissatisfaction and loss of original brand reputation. There have been cases where the products sold in gray market sales are outdated or old, no more into use or have crossed their expiry date that have affected the consumers. This has an acute and dangerous effect when it comes to the pharmaceutical industry with medicines being sold even after their expiry date. All these put together results in health hazards, monetary loss and loss of consumer goodwill.


How to combat Gray Market sales


Today service providers specializing in enterprise risk management has come up with innovative solutions to combat gray market sales, that also helps you to retrieve the lost brand image and market share by making the value chains tighter. These companies have set up an advanced web mining and reporting technology that provides enterprise visibility beyond the supply chain. The solution also provides a prioritized actionable data against any kind of fraud practices. The solution enables end users to halt counterfeits and gray market sales and can also monitor a wide selection of sources globally that includes B2B sites, auctions, and gray market emails and many more. The moment a fraudulent activity is detected, the supply data are prioritized and analyzed within the solution and offered to take the necessary actions.


Read More About:  Counterfeiting, Brand Management, Anti-Counterfeiting

Anti-Counterfeiting Solutions for Today’s Enterprises

Today’s techno savvy world has provided enterprises with a number of opportunities to spread globally. The growth of e-commerce has further paved way for the enterprises to gain a strong web footing. However, these innovations have also paved way for the cyber criminals and counterfeiters to spread their presence globally making the counterfeit products popular.


The demand and popularity of the fake products in the market have made counterfeiting as one of the fastest-growing economic crimes prevalent today across all industry verticals. Wikipedia defines  counterfeiting as “ the manufacturing and selling of illegal imitation of products, brands, documents, software, works of art, trademarks, patents and even currencies with an intention of deceiving the customers”. The counterfeited goods or 'knock-offs' have a widespread market base. The  Counterfeiting Intelligence Bureau (CIB) of the International Chamber of Commerce (ICC) has recorded that on a global scale the  counterfeit goods make up 5 to 7% of World Trade, amounting to an estimated $700 billion a year. Enterprises thus need to invest in robust anti-counterfeiting solutions.


The spread of the Internet and e-commerce has facilitated the selling of a large number of counterfeit products through various online shopping sites. Counterfeit goods have thus become widespread making it difficult to monitor, affecting the enterprises bottom line. The increasing number of high-profile counterfeiting episodes, not only affects the consumers but also has a deep impact on the brands. Enterprises thus need to have a cohesive anti-counterfeiting strategy that works in tandem with the enterprise requirements.


With the globalized environment and the counterfeiters being well-equipped and skilled, anti counterfeit solutions from leaders in  the industry are no longer just a single division responsibilities but are intelligent, intuitive ones that span the entire enterprise. The solution effectively gauges and measures the actual impact of counterfeiting on a product and its brand reputation. The anti-counterfeiting strategy includes:


* Trademark protection the backbone of anti-counterfeiting efforts. The presence of Intellectual Property lawyers either on a contractual basis or in-house fortifies the anti-counterfeiting strategy.


* Trade groups are valuable elements of anti-counterfeiting efforts. By working with trade groups that share the same common interests, enterprises can efficiently protect their intellectual property especially in vertical markets. Further, this facilitates enterprises with diverse and cost effective methods to prosecute counterfeiters.


* Global monitoring of web commerce with a back-end database which facilitates organizing the collected information into actionable intelligence.


All these components go a long way in brand management and brand reputation while ensuring that the quality and reliability standards meet the consumer's expectation levels. The anti-counterfeiting solutions thus help enterprises to withstand competition as well as receive high-returns in revenue.


Read More About: Enterprise Risk Management, Gray Market

Global Supply Chain Solutions Simplifies Supply Chain Management with Improved Precision

Today's business climate has rapidly changed and become more competitive. Businesses need to operate at a lower cost to compete, and must also develop its own core competencies to distinguish itself from competitors and be noticeable in the market. Due to globalization, supply chain management has become a tool for companies to compete effectively either at a local level or on a global scale. SCM has become a necessity especially for manufacturing industry when it comes to deliver products at a competitive cost and at a higher quality than their competitors. Strengthening the supply chain cycle is the key to attaining operational excellence and business success and a company can achieve great benefits with an efficient and effective supply chain management.


Supply chain solutions can be of great importance to every business organization, and the right supply chain solutions can help in lowering operational expenses with timely planning for procurement, manufacturing and transportation. Efficient supply chain solutions manage different networks of interconnected businesses involved in delivering the products or services to the end customers.  The complexities of a supply chain makes it important to consider the function of supply chain logistics, namely that of distributing products from one place to another.  


These solutions simplify service management with improved precision as businesses need to address a number of issues when dealing with a global supply chain. They take into consideration the combined influence of all the organizations engaged in the production of services and goods, from manufacturers to suppliers, retailers, wholesalers to the customer. A flexible and integrated system ensures an efficient supply chain management, for which it is essential to have a transparent and a well-structured process.  


In today’s competitive business environment, customer satisfaction and customer loyalty are the vital aspects that determine the successful existence of any enterprise. Without doubt, successful organizations of the future will be operating in an environment of well-integrated supply networks communicating over web-based information systems. Implementing the right supply chain solution can help in improving service levels and reducing operational and IT costs. The right supply chain management solutions can help in lowering operational expenses with timely planning for procurement, and retail fulfillment.


Efficient supply chain consultants offer accurate and valuable advice on the long-term strategy for your business and ensure that the advice will fit in with your overall business goals and plans.


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Optimized Solutions for an Efficient Global Supply Chain

The success of every business, irrespective of its size of operation depends on its logistic functions. The efficiency of the logistical functions is further dependent on its supply chain. Today with enterprises moving towards the global fold, supply chains have become increasingly complex. Along with the expansion of business and entering new markets, enterprises also tend to support various strategies for business survival in the competitive environment which includes increasing delivery speed and cost reduction.


However, to make their strategies successful the global enterprises consider offshoring and outsourcing, making their supply chain a vital aspect of the business environment. The supply chain solution integrates the logistics and manufacturing functions and coordinates and collaborates between channel partners, supplier, third party service providers and customers which build the business into a cohesive unit. The global supply chain  is a larger framework built on cross-functional business processes that are global in nature. With each of the business process being managed by a team of logisticians, production specialist, finance, marketing and research and development professionals, the global supply chain management is a vital aspect of the business environment.  


With a number of countries involved, the global supply chain management is challenged by the need for reduction of overall costs and time. The overall cost which is related to the expenses and tariffs as a result of overseas business and exchange rates need to be considered well in advance before embarking on logistic supply across nations. The time that needs to be reduced is related to the time required for production, procurement time, delivery and extended shipping times from overseas locations which has a great impact on the global supply chain. Unlike the supply chain solutions which handled a national level logistics through just-in-time deliveries with shorter lead times, the elongated global supply chain challenges enterprises with forward logistics of longer lead times and bigger batches besides efficient handling of reverse logistics supplies too.


The leading service providers have collaborated with the IT giants to provide enterprises with a   technology platform integrated with a number of software solutions. Such high-end technology will provide global enterprises with a strong backbone for its logistics operations. The technology platform will not only support business intelligence but will also efficiently handle customer relationship management and logistics management besides providing a real-time mode for client reporting. By leveraging on this technology, enterprises can integrate the network assets through an easy global supply chain and ensure an efficient logistics handling across the wide market. A reliable supply chain provider with efficient and scalable services to meet the growing customer demands will ensure robustness of the global supply chain system.


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