Emergence of Systematic Regulatory Services

Owing to the occurrence of chronic ailments, India has risen up to it by developing its present treatment modalities and drug development process. In keeping with the developments, India in the recent past have gained the titled of one of the most “preferred hub” for medical tourism. Innovative and advanced medical studies and researches for finding out better cures and treatment needs a systematic research and development process and regulatory policies that ensure the quality of clinical trials and trial output.


This cause has made numerous Indian CRO’s (clinical research organization) come up with high-end clinical laboratory services that helps in better disease treatment and systematic drug development. The medical technicians and doctors today carry on medical researches and medical studies along with assessing human blood samples, to evaluate the availability of the active drug in blood and the period of availability of active drug in blood which helps to decide the dosage schedule for the patient. Apart from this CRO’s also give emphasis on regulatory compliance and proper quality assurance. Most Indian CRO’s have a dedicated team for regulatory services as well as audit compliance that is backed up by a vast know-how on the local regulatory processes and meaningful liaison with other regulatory agencies thereby assuring accuracy in the clinical trail approval procedure.


Indian CRO’s that specialize in regulatory services has efficiently conducted multiple audits in numerous Indian and global regulatory agencies. In addition to that, they have also researched on the study submission from various countries. The host of regulatory services provided by Indian CRO’s is:


  • Formulating regulatory strategies

  • Replying regulatory agency queries

  • Renewing Import License

  • Procuring drug import licenses

  • Follow-up and submissions on the application

  • Tracking applications and approvals

  • Submission of Clinical Safety Report (CSR)

  • Safety Reporting

  • Procuring NOC for export of biological samples

  • Compiling a clinical trial application


This apart, concerning regulatory policies and quality assurance the Indian CRO’s also have their own quality assurance team to manage the medical practices with quality. This team concentrates on the quality that goes through the procedures within the domain of every single medical process. Furthermore, there are certain executions that are conducted by the Quality Control and Quality Assurance procedures. The Quality Assurance practices generally spans across Bioanalytical and Bioavailability studies, Statistics, Clinical, Internal Audits and Reporting by the QA team for any area specific SOP compliance. There are other in-house capacities too that CRO’s conduct and it comprises various aspects such as Site Audits, Vendor Audits, Process/System Audits, and Document.


Read More About: Clinical Pharmacokinetic, Biometrics

Advanced Usage of Biometrics Services

With medical science developing manifold, today biometrics are used successfully in several scientific studies and forms an integral element of forensic science and is an essential element of access control systems. It is helpful in maximizing the security level and also makes the identification and authentication process easy, fast and convenient. Formerly, biometrics seemed to be expensive especially due to the economic constraint and the individual data protection rights were restricted. Biometrics information changes irrevocably the link between the identity and the body, as they make the features of a human body machine readable and is also subject to any further use.

Biometric data can also be processed and saved in various forms. There are times when this data captured from an individual is processed and saved in a raw form and it enables to identify its source, such as the voice recording, fingerprint picture, face picture and many more. There are times when raw captured biometric information is processed in a specific way that only chosen features get saved and extracted as a biometric template.

Adaptive biometric Systems aim to auto-update the templates or model to the intra-class variation of the operational data. The two-fold advantages of these systems are solving the problem of limited training data and tracking the temporal variations of the input data through adaptation. Recently, adaptive biometrics have received a significant attention from the research community. This research direction is expected to gain momentum because of their key promulgated advantages. First, with an adaptive biometric system, one no longer needs to collect a large number of biometric samples during the enrollment process. Second, it is no longer necessary to re-enrol or retrain the system from the scratch in order to cope up with the changing environment. This convenience can significantly reduce the cost of maintaining a biometric system. Despite these advantages, there are several open issues involved with these systems.

Indian CRO’s (Clinical Research Organizations) today offer a comprehensive range of data management services in the bio-equivalence and Phase I to IV clinical trial that are carried on bio clinical laboratories of the CRO’s. The biometric services offered by the CRO’s include the following:

 Database Programming

  • CRF Design (paper & electronic)
  • CRF Annotation
  • Database Programming
  • Validation Checks
  • Metadata Repository Management

Data Management

  • Data Acquisition
  • Data Reconciliation
  • Discrepancy Management
  • Medical Coding (MeDRA & WHODD)
  • Database Lock
  • Data Extraction for Reporting

Pharmacokinetic & Pharmacodynamic Studies

  • Sampling Point Estimation
  • Technical Document Review
  • PK/PD Query Resolution
  • PK/PD Subject Matter Expert
  • Pharmacokinetic support across study engagement

PK/PD Reporting

  • SDMS Data Extraction
  • PK Data Analysis
  • PK Summary Reporting

Biostatistics

  • Randomization
  • Sample size estimation
  • Trial Design Inputs
  • Statistical Analysis Plan
  • Statistical Analysis
  • Biostatistics Subject Matter Expert

Statistical Reporting

  • TLF Programming
  • CDISC Data Mapping (SDTM & ADaM)
  • Clinical Data Repository
  • Pooled Data Analysis & Reporting
  • Safety (ADR) Reporting
  • Patient Profiles & Data Cleaning Reporting

The primary objective of biometric companies is to convert raw data to accurate and reliable trial results that remain compliant with selected regulatory services and policies. In addition to that, these companies have their biometric teams that work in order to accelerate the regulatory submission process and reduce timeline.

Read More About:  Biometrics CompaniesClinical PharmacokineticBioavailability

 

Turn Returned Product Back into Cash with Reverse Logistics

The APICS Dictionary defines Supply Chain Management as the “design, planning, execution, control, and monitoring of supply chain activities with the objective of creating net value, building a competitive infrastructure, leveraging worldwide logistics, synchronizing supply with demand and measuring performance globally." Thus SCM is concerned not only with the flow of finished goods from the point of manufacture to the point of consumption but also with the reverse flow of unsold and unwanted goods from the point of consumption to the point of origin for reuse, recycling or disposal. The forward flow of finished goods is referred to as forward logistics while the reverse flow of goods is referred to as Reverse Logistics. Thus reverse logistics is defined as "the process of planning, implementing, and controlling the efficient, cost effective flow of raw materials, in-process inventory, finished goods and related information from the point of consumption to the point of origin for the purpose of recapturing value or proper disposal.


Reverse logistics is often considered as an expense or an additional financial burden to an organization. However, the fact of the matter is that it offers several tangible and intangible benefits to the organization. Here is a look at some of its benefits.


* Improves Company Credibility and Reputation: as reverse logistics allow the enterprises to take care of e-waste and other hazardous waste, enterprises stand to gain a good standing of being a responsible company.


* Reduce Costs: reverse logistics help to minimize overall costs by taking back unsold and unwanted goods back to the manufacturer so that it can be taken apart, sorted reassembled or recycled to be sold again in the market.


* Improve Customer Satisfaction: reverse logistics help to improve customer satisfaction by taking back faulty goods back to the manufacturer for repair and replace it with a new one.


* Gain More value: as unsold / unwanted / returned goods mean loss of time, money and effort, reverse logistics help in gaining more value by sending it back to the manufacturer for reuse or recycling.


Considering the substantial positive effect reverse logistics can have on business, enterprise needs to partner with good third party logistics providers to manage product that comes back from the field. The following are some of the returns management capabilities of a 3rd party logistics provider.


* Detrash and destruction of returned materials (CDs packaging materials  etc.)

* Date code based warranty assessment

* Test diagnostics and repair

* Software and/or firmware upgrades

* Refurbishment

* Repackaging

* Warehousing and Distribution

* Legally compliant disposal (i.e. WEEE and SB2050)

* Web-based inquiry and reporting


Thus, reverse logistics help to turn returned product back into cash quickly and with no hassle – all the while improving profitability and efficiency.


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Integrating Processes with Supply Chain Solutions

The success of every business lies on its efficient supply chain systems.  The delivery of goods and services is an integral part of the business process and forms the basis for the supply chain system.  The supply chain needs a great deal of coordination between various process such as procurement, inventory control, allocation, production, transportation, logistics and distribution. However, in today's globalized business environment with enterprises having widespread customer base  and offices across geographical boundaries, maintaining an efficient supply chain is challenge faced by the global enterprises


Defined as the movement of products or services from the suppliers to the customers, the supply chain starts in the form of raw materials and ends up with the retailers and customer as a finished good. In order to meet the order fulfillment requirements of the customers and retailers, every business house depends on  their fulfillment departments to cater for these requirements. Being the core function of every business, the widespread enterprises with an aim to launch new products and services needs a robust supply chain solution . This has given rise to a number of enterprises that have forayed into providing fulfillment solutions that can be customized as per the organizational goals and objectives of the globally bound organizations.


Technological enhancements paving way for organizational focus on both B2B and B2C markets, the leading service providers offer their clientele supply chain solutions that can be integrated with fulfillment  solutions, supply base qualification and Procurement,  Systems integration, configuration and tests, logistics and distribution, Returns management and reverse logistics, Inventory Control, Order Management retail packaging, retail distribution,  as well as an on-line Inquiry and Reporting systems. Such integration will help these enterprises  to manage the challenges faced. Further, being a totally  integrated supply chain solution, this  includes ideal retail distribution system that facilitates a hassle free distribution and transportation of goods and manages the complete supply chain  package.


Today with the world-wide  presence and a strong web footing, most of the  enterprises  have a with them a team of experts with vast experience. This enables the global enterprises to deliver world-class retail distribution with improved productivity with  reduced costs. Further, the technological growth, widespread distribution services, manufacturing and distribution hubs and in-house IT capability, enterprises are well equipped with complete visibility that facilitates a seamless and effortless system integration leading to  strong supply chain solutions. Experts in the industry sector are armed with  through knowledge of market trends. The logistic and distribution of any new product need to ensure that they follow the necessary packaging metrics as per customer requirements and also needs to ensure that the right package reaches the right customer.


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Easy Ways to Cut Down Gray Market Sales

Gray market according to AGMA is the unauthorized sale of fresh authentic branded products and goods craftily diverted from authorized distribution channels or are imported to a region for sale without the approval or knowledge of the manufacturer. Whilst gray market practices have multiple reasons to thrive, such as channel integration and product availability, its root cause is however associated with heavy price differentiation between markets. As per an AGMA research approximately $40 billion products are sold each year in the gray market and the total gray market activities sums up to $5 billion in lost profits annually to manufacturers.

The impacts of gray market activities to the channels include, unstable prices, erosion of margins and price, reduced value of authorization status and co-mingling of gray market with the authorized inventory. Similarly the impact of the same to end users includes consumer dissatisfaction in brand, missing or increased option, increased service incidence rate, exposure to counterfeiting or used product and lack of warranty. Therefore, enterprises and business houses need to come up with ways and means to address gray market concerns. Some of the methods include:

  • Creating a corporate awareness
  • Reviewing entries in the organizations distribution channel
  • Efficient serial number tracking

Whilst the above mentioned ways would yield positive results, it is also useful to invest in an efficient enterprise risk management program. Such programs offer brand protection via SaaS based software that helps to put an end to gray market sales. The software manages the open market on a continuous basis for sell/buy listings of goods and part numbers making use of advanced search agents that can track detailed market information from a wide range of market types, such as: 

  • Franchise and large distribution websites
  • Independent and gray market websites
  • Email-based forums that aggregate buy/sell listings
  • Trade boards
  • Auction sites
  • Chat
  • B2C sites
  • Blogs
  • B2B sites

 The software also helps in providing data directly via a website to the user in a comprehensive, multi-dimensional market intelligence format. Using these format end users can have customized dashboards; report views and even create user formatted export files. This apart, all essential information can be accessed and used within a perceptive interface. This allows the investigators to manage and create case histories, evaluate evidence and better understand the association between suspect organizations, partners and other related contacts.

Internet technology has been proficient in promoting online trade but it has also promoted fraudulent practices. Therefore, investing in advanced brand protection solutions will help you to cut down on gray market sales.

Read More About: Anti-CounterfeitingBrand Management

 

Avoid Profit and Brand Erosion Caused By Grey Market Sales

Gray market sales are not only a hindrance in emerging markets, but a global problem that needs a global solution. Gray market goods usually include products with legitimate trademarks that are intended for sale outside a country but their sales usually occur when the price of an item is significantly higher in one country than another. In a nutshell, entrepreneurs buy the product from the country where it is available cheaply, at retail or sometimes at wholesale prices, import it legally to the target market, and sell it at a profitable price but below the normal market price. But enterprises need to keep in mind that while the estimates of gray goods vary by industry, the value is substantial.

Understanding what the gray market actually means

 

The sale of gray market products is not covered under the original manufacturer’s warranty and impacts the customers who assume that the product they bought carries the original warranty. As products find their way into the gray market through unauthorized channel, they sell these products   at a higher discount,  affecting the enterprises’ revenues and legitimate channels as well. Unlike the black market, gray market goods are not illegal; instead, they are sold outside of normal distribution channels. Besides representing the products as legitimate, the entire gray market sales process takes sales away from new products, and affects the distributor loyalty.

Why is it usually difficult to detect the offenders?

E-commerce is said to be the primary driver of this ever- growing gray market activity. While some Internet sites blatantly advertise different gray goods, most gray marketers are careful and hide this fact.  With the lack of coordination between countries, weak laws in some regions, law enforcement agencies’ are unable to detect and prosecute grey marketer.

Effective Solutions are the need of the hour

 

In today’s competitive environment, companies need to be aware of counterfeiting, gray market, trademark infringement and much more in order to stay afloat. They need to deploy brand protection software that can protect their brand and trademark from exploitation.

Today companies specializing in online brand protection solutions have come up with SaaS based software solutions that help you to combat gray market sales. These solutions-providers offer cost-effective brand protection solutions that use advanced search technology to monitor activity for any number of products globally. It picks up pricing, discount percentages, and quantities for each product and helps to quickly identify the companies that cause loss of revenue, brand, and customer satisfaction. Invest in the right solution to proactively recapture lost revenues, market share, and brand reputation by tightening your distribution channel.

 

Read More About: Enterprise Risk Management, Brand Management

 

 

Educate Your Employees About Phishing Awareness

Most of the times the data attacks and Phishing attacks happen you are unaware. That is to say when you are browsing the internet for some information or checking your mails and come across unknown links, URL address and pop ups that look authentic at the first glance but invariably lead to your fraudulent websites selling faulty goods or the ones that asks you to share your private data like bank account details, mobile number, email id and many more.


This is the way in which most Phishing attacks operate. Phishing is an after effect of social engineering where the Phishers and hackers aim to steal all the personal details of an organization and cause losses like data theft, tarnishing of brand reputation, loss of market share and revenue. There are times when a single Phishing attack has caused the entire computing network to fail and loss causes could not be retrieved despite implementing anti-virus and anti-spyware protection and other security firewalls. The modern day hackers are smart and have come up with complicated and sophisticated Phishing attacks that look like genuine mails and URL links. Therefore, it is essential that companies resort to efficient measures in implementing Phishing protection programs so that they can avert the losses and other difficulties.


More than anything else social engineers and Phishers work on an individual or employee’s ignorance and unpreparedness about Phishing attacks. Most people do not know the way Phishing mails are especially created to target global brands and enterprises. Hence, it is essential to have Phishing awareness programs where a company takes the time to make it clear to their employees the ways and means by which a Phishing attack is carefully planted. Mails such as winning a huge lottery amount or a lucrative career opportunity based on a “lucky draw” on e-mail id’s play on the individual’s sentiment and trick them to submit their private data.


However, service providers today have introduced high-end anti-Phishing software that offers detailed statistics on the employee response and behavior on Phishing attacks, security awareness and also recognizes the scopes for potential data leakage and evaluates the data loss prevention. Few other important features are:


* Helps enterprises in estimating the probable threats associated with Phishing

* Offers flexible reporting capacities and incorporate them back into the enterprises’ main performance-indicator framework

* Offers a “road map" solution highlighting on Phishing awareness and training within the organization

* Recognizes weakness within people, process and technology links

* Helps in prioritizing remediation attempts via effective benchmarking and maturity evaluation


This apart, the software assesses the incident response program and a sends a customized test to the employees informing them about their actions. Furthermore, there is an e-learning module that helps to educate employees about Phishing protection.


Read More About: Simulated Phishing Attack, Protection From Phishing, Anti Phishing Software

Measure your Online Effectiveness in Facebook?

Interacting online and online conversations have become an essential aspect of social networking and monitoring. Previously, the same used to be tagged as “idle chatting”. However, with the advent of the social web and social media interactions it has become very important for almost every brand established or a start-up venture to stay online and contribute meaningfully to social networking.

 

It is important to note in this regard, staying online does not necessarily mean posting random news updates or information for the sake of staying online. It is essential to estimate how efficient and effective is your online marketing, branding and PR initiatives are. It is equally important to have a clear knowledge on how much traffic your website generates from social networking websites, for instance Facebook or Twitter. These vital inputs, often termed as social intelligence helps you to ascertain whether your social media marketing initiatives are working or not.


Social media analytics tools are the apt medium that helps us have a clear understanding about the website traffic and how much it is generated through online networking. Facebook today has its own advanced analytics that concentrates on the shared content and user demographics. Users can download data regarding regular visits and the percentage of likes and comments. It is essential to have it in mind that the data emphasizes completely on the Facebook page and has no link to the homepage.


However, if Facebook is your social networking website then you must leverage the Facebook analytics that several service providers offer today. This is an effective medium that helps is estimating quickly the success of the Facebook campaigns making use of a mix of analytical smarts along with a Facebook analytics solution that provides fast results for business to keep a track of the web data, getting engagement metrics and real-time distribution. It also has the capacity to attain instant feedback and helps the consumers to optimize their campaigns, products, features, interactions and contents faster.


Apart from this, the solution also has a simple virtualization interface that provides both drill down capacities and trending views providing intuitive insights to come in quicker, smarter business decisions even amidst a huge selection of data. Furthermore, it also helps the end user to gain insights into the key impacts on the K-facto, viral campaigns and understand as to what keeps a certain section of the audience engaged can impact the revenue generation.

Identify and Predict Consumer Behavior with Social Media Analytics Tools

Today enterprises have a tough time in making an impact upon the customers. This is because today’s customers buy products if and only if the products appeal to their preferences. There was a time in the past when enterprises had the last word, but today things are different. Thanks to social networking, customers today have the first and the last word on anything and everything let alone products. With people sharing their likes, dislikes preferences, opinions, perceptions, suggestions, and comments online, enterprises have to be careful when marketing their products. Hence, what enterprises need is social media analytics tools to identify, predict, and respond to consumer behavior.


Here is a look at the benefits of a best of breed social analytics tool:


* Analyze data in real-time from across social, mobile and web platforms to allow game developers and social commerce companies to continuously improve customer acquisition, engagement and social game monetization campaigns.

* Modernize your ability to capture broad data, uncover meaningful insights, and close the loop with automated action – all in near real-time.

* Track user behaviors in real-time and get immediate feedback on what is working vs. what isn’t so you can optimize on the fly.

* Use visualization interface that helps you truly understand business performance to make faster, smarter operating decisions.

* Real time data and actionable insights to help you reach faster, smarter operating decisions.

* Provides results in seconds for businesses to track user behaviors in real-time and get immediate feedback on what’s working and what isn’t so you can optimize products, features, campaigns, and interactions on the fly.

* The easy-to-use visualization interface provides both trending views and drill-down capabilities

* Faster insights into the key influences on your K-Factor and virality campaigns, understand what keeps customers engaged, and uncover the levers that can most affect revenues.

* Easy to get up and running.

* Measure the effectiveness of acquisition campaigns and conduct funnel analysis on viral features and promotions

* Monitor virtual currency monetization and trend metrics like ARPU, ARPPU, conversions, payment type, etc

* Get actionable insights into their most-used app features and what drives monetization to make faster, smarter operating decisions.

* Create user profiles to target and customize app content to the most-engaged (and most valuable) users, such as frequent visitors or frequent purchasers

* Get deeper insights into the demographics of users with information provided through Facebook’s Social Graph API

* Provides trending views and drill-down capabilities

* Insights to make faster, smarter operating decisions across huge amounts of social data.

* Acquisition to revenue.

* Get faster insights into the key influences on your K-Factor and viral campaigns

* Understand what keeps customers engaged, and uncover the levers that can most affect revenues.


Thus, good social media analytics tools help to modernize analytics by going beyond simple metrics and measurements, and thereby allowing enterprises to focus on a broad array of data and mine the vast treasure trove of social media to understand which events, content and user segments drive the most revenue.

Benefits of Supply Chain Solutions

The modern day business today is a global platform that compels organizations, irrespective of its location or primary market base, to consider the world in their competitive strategy analysis. The firms cannot ignore external aspects such as competitive situations, economic trends and technology innovation in other places. Today most organizations are truly becoming global with their supply chain management strategy and are changing their ways in which they used to monitor their operations and logistics practices. Modifications in trade and modernization of transport infrastructures and the competition intensification have upgraded the significance of flow management to new levels.

 

Supply chain solutions can be described as a set of three or more organizations associated directly with one or more than one of the upstream and downstream flow of goods, services, data and finances from the source to the consumer. It comprises of all the levels involved, indirectly or directly, in catering to a consumer’s demand, it not only comprises the suppliers and manufacturers, but also the warehouses, transporters, retailers and the consumers themselves. Within an enterprise the supply chain comprises of every function included in catering to consumer demand. These functions include components such as:

 

  • New product development
  • Marketing
  • Operations
  • Distribution
  • Finance
  • Customer service

 

Therefore, it is essential to partner with a supply chain consulting firm so that you can leverage its experience and expertise. Companies specializing in supply chain solutions help you to minimize your operational expenses, enhance the speed, elasticity and bring down the level of risks.

 

If you have assessed your company’s supply chain and evaluating its weaknesses, strengths and want to see the scopes of possible solutions and improvements then its best to invest in a supply chain solution. Today service providers of reverse logistics have come with up advanced supply chain solutions with a supply chain consulting team that helps companies to reshape and restructure their operations in order to increase speed, efficiency and the flexibility. Some of these service providers specialize in last-mile interventions that help in adjusting over-offshore supply chains. Owing to the fact that every business has its own unique need and demands, the supply chain consulting team has the expertise to customize the systems that is provided rather than taking on a “cookie clutter” approach.

 

Service providers of supply chain solutions work by understanding the business requirements first and provide solutions that are practical and attainable. The service providers will straight away not suggest you to re-establish your operation but rather suggest the much needed solutions.

 
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