Changing Trends In Indian Clinical Trials

Indian clinical trials along with the overall healthcare vertical today are at an inflection point and are estimated to expand in the long run. However, the Indian clinical expenditure ranks still one of the lowest globally and there are other critical challenges too that needs to be addressed in terms of quality patient care and availability of health care services.  Though this represents a crucial scope for the private sector the Government sector too has an essential part to play it making the evolution possible.


The health care and the clinical trial expenditure when compared with regards to the public-private contribution, also indicates a distorted picture. It has been estimated that the private sector contribution to the Indian medical sector had been 75 percent and is considered as the highest globally in terms of percentage. The public expenditure on the other hand is estimated to be the lowest globally and is also 23 percent less than the global average.


However, apart from these statistical details changes in lifestyle and the emergence of new chronic ailments have given rise to the amount of clinical trials in India. This branches out from the intricacy of the non-communicable and communicable diseases both in the urban and rural regions. The occurrence of chronic disease patterns has influenced the medical infrastructure needs and has also resulted in the architectural challenges for the government as well as the private players. It has also been observed that India often gets rated poorly on the fundamental health care factors when it is benchmarked against developed economies as well as the BRIC nations. This indicates that a huge part of the Indian population is not able to have proper access to health care services. This is a result of:


* Absence of proper medical infrastructure

* Absence of qualified and trained manpower

* Absence of proper regulatory services and quality assurance


Keeping these aspects in mind Indian CRO’s (clinical research organizations) today conducts regular clinical trials concentrating on Phase I to IV medical studies. These CRO’s apart from carrying out innovative drug development and treatment process also carries out research on innovative medical studies on biometrics, medical writing, clinical pharmacokinetic, and other variations of bio-analytical studies. In additional to that, the CRO’s also excel in multiple therapeutic areas and studies related to bioavailability.


Thus, the major objective of having systematic and organized clinical trial phases is to come out with innovative treatment methods and healing modalities so that the rate of chronic ailments can be reduced eventually.

Importance Of Online Brand Protection

With the web becoming more dynamic and an essential part of every enterprise, it has become increasingly important to become proactive in identifying the brand abuses and exploits that happen online and tarnish brand reputation. Brand violation activities by cyber criminals negatively impact business operations by consolidating their internet domain name. Therefore, a protective online brand protection solution needs to be implemented.

 

When products are sold in online gray markets it affects the brand reputation of the enterprise. Furthermore, these enterprises lose important market share for not being able to arrive at a solution to protect their brand reputation. It is also essential that the higher management realize the significance of brand reputation management and the way it can influence short and long term objectives. Today there are online brand protection solutions that help in identifying gray market channel. The solution is also efficient in prioritizing violators and recognizing the syndicates that cause maximum brand erosion.

 

According to Gartner, the ideal online protection program should be well coordinated, cross departmental and needs to undertake an automated approach that goes beyond the legal department and includes marketing, brand management, risk and supply chain management and loss prevention. The program should be active in tracking the brand abusers before they repeat the same attacks and resolve any issues of brand erosion and divert site traffic efficiently. In order to implement such a program the essential steps to take are:


* Recognizing all domain names in the service portfolio

* Monitoring the portfolio efficiently

* Monitoring for potential online abuses

* Responding to abuses


Some of the potential brand abuses take place in the following form:


* Cyber squatting

* Domain abuse

* Trademark infringement

* Traffic diversion schemes

* False associations with unrelated third parties

* Pay-per-click abuse

* Sponsored link abuse

* Logo and image abuse

* Offensive content

* Channel non-compliance with brand guidelines and/or pricing

It is important to keep your brand free from counterfeiting and gray market sales. Advanced online brand protection solutions apart from detecting counterfeits also help in putting an end to illegal brand operations. The solution efficiently and automatically send, cease and desist and DMCA letters. In addition to that it also offers automatic shutdowns. Furthermore, the solutions come with a network of authorized investigation as well as legal partners that helps end users to streamline the enforcement process and in turn helps to maintain a positive brand image.

Read More About: Enterprise Risk Management, Anti-Counterfeiting

Phishing Awareness – A Key Defensive Method

The technologically enabled business world networked through the Internet and corporate networks has made the world connected and smaller. While these benefits every customer, business hours, vendors and end-users tremendously by making everything from business critical data, products and services available at the click of a mouse,   it also challenges the enterprises with security threats. These threats from the cyber criminals tend to harm not just the individual systems but the network of IT infrastructure and the corporate landscape are also at risk.

The wide use of the internet has paved way for Phishing attacks to be used as a popular tool by the cyber criminals. Being one of the fastest growing forms of Internet attacks, these can cause havoc for the enterprises and the end-users. The enterprises thus need to take proactive steps towards protecting the brand, assets and intellectual property. The use of anti- phishing tools and creating strong phishing awarenessamong the users will go a long way in phishing protection.

The anti-Phishing software from the leading developers proactively locates the threats to the organization irrespective of being hidden or public, targeted Phishing attacks or malware.  Phishing attacks by criminals’ tricks the customer into voluntarily providing personal details or critical information that can be subsequently used by them for identity theft, access account or leak out vital business information. Besides the use of anti-phishing tools, a key defensive mechanism that can be used by the enterprise to gain protection from phishing is to ensure that the employees and the distantly distributed teams and mobile workforce have enough phishing awareness.

Though the anti-phishing solutions designed and developed by leading service providers in the help enterprises to protect the vulnerable people and process against any phishing attacks, the security awareness programs adds on to the benefits by being the best line of defense against the cyber criminals. Such educative measures will help the employees and customers to recognize the Phishing attacks when they occur and be on guard for these attacks by protecting all vital information without disclosing it.

With Phishing scams becoming more and more sophisticated, the use of anti-Phishing software helps save costs and prevents losses in business. Enterprises thus need to invest in advanced anti-phishing solutions which can combat the threats, provide statistics on user behavior, measure the level of phishing  awareness among employees, identifies data leakage and scale up to provide phishing protections as per the organizational requirement.

Read More About: Anti Phishing Tool, Simulated Phishing Attack

 

 

Increase Phishing Awareness through Anti Phishing Software

The most valuable asset of any enterprise is not its financial, equipments or services but its employees. This is because it is the employees who play a pivotal role in putting enterprises on the success track through their innovative ideas and successful marketing efforts. However, these very same employees can be responsible for significant financial losses for enterprises in the form of lost customer trust and decline in shareholder value. Just a small slip from their side is enough to cause their fall from grace. And in today’s digital world, the most unpardonable mistake is that of succumbing to cyber attacks.

Of the different cyber attacks that target companies and organizations, the most notorious is social engineering, which is “a non-technical kind of intrusion that relies heavily on human interaction that involves deceiving someone, either in person, over the phone, or using a computer, with the express intent of breaching some level of security either personal or professional.” One of the most popular social engineering techniques is phishing, which is “the fraudulent practice of sending e-mails purporting to be from legitimate companies in order to induce individuals to reveal sensitive information.”

Social engineering and phishing have become major concerns across the world, as the attacks are so refined that they are hard to identify and avoid. While current products and services may address the "process and technology" aspect of security, few solutions adequately address 'people risk'. Hence, what is required is a unique approach that goes beyond process and technology to address people risks as only through phishing awareness that people can avoid becoming phish bait in the future.

Effective anti Phishing software is what organizations need to protect their most valuable assets -- their employees, from becoming Phishing victims. It proactively educates users and helps them identify Phishing attacks. It simulates a Phishing attack and captures user's potential reaction to a real attack. Here is a look at some of its benefits.

  • Helps understand user behavior and effectiveness of the People controls across the enterprise
  • Assists organizations quantify the potential risks of social engineering
  • Provides flexible reporting capabilities with integration back into the organization's key performance indicator framework
  • Provides a road map for building security awareness and training within the organization
  • Identifies weakness within People, Process and Technology links, allowing prioritization of remediation efforts through effective benchmarking and maturity analysis
  • Generates a “Teaching Moment” that provides a safe, customized learning experience for users – resulting in increased employee awareness and knowledge that helps protect the sensitive information entrusted to them.

Anti Phishing tools help organizations to build the first line of defense by increasing an employee's awareness to Phishing.

Read More About: Protection From PhishingSimulated Phishing AttackPhishing Protection

 

It is Easy To Combat Phishing Attacks

Social engineering and Phishing are the two greatest concerns of the IT world. It is impacted global organizations with acute spear Phishing attacks that are so complicated and sophisticated that it becomes difficult to identify and avoid them. These attacks are created and planted by the cybercriminals and social engineers to steal critical data and then share it with third party intruders. This data gathered can vary from any kind of private data to corporate information.

  

Phishing attacks usually have a negative impact on an enterprise’s image and brand equity. It can result in monetary losses and also loosing of consumers trust and decline of shareholder value. All this can take place once an employee becomes a victim of a Phishing attack. Hence, it is crucial to search out ways for Phishing protection in a cost-effective and simple manner that would make employees aware of its consequences. 

 

The Way Phishing Works 

Simply put, Phishing is a criminal strategy that implements both tactics of technical deception and social engineering for stealing identity, financial and other personal data. Social engineering plans make use of fraudulent and hoax mail content and claims that they are from authentic sources. This ends up in leading recipients to faulty websites and URL links. These websites are set up by Phishers in order to steal important data that comprises passwords, usernames, bank details and many more.

 

There have been innumerable Phishing awareness programs that promised to secure companies against technology attacks. Two vulnerable areas here are the people and the process. A strategicPhishing attacks mostly aim in these two specified places. The third party intruders are aware that these are difficult zones to safeguard.

Keeping these concerns in mind, today solution providers have developed high-end anti Phishing software and programs to combat Phishing attacks. It comes in the form of an automated device that is installed internally in an organization where the process, people and technology details are fed it. After this a simulated Phishing attack is generated at the target audience and then the solution traces the user response. The social responses towards this attack are assessed and a detailed report is generated depending on the responses. Anti-Phishing solutions also offer statistics on user behavior, evaluates the security awareness percentage amidst employees, evaluates Data Loss Prevention programs, recognizes data leakage and examines the incident response program. All these put together, secure a company from unwarranted Phishing attacks and resolve the ones that have already taken place.

Read More About: Anti Phishing Tool

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.


Other Links - data center integration

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.


Other Links - data center integration

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