Significance of Regulatory Services in Clinical Trials

According to GCP (Good Clinical Practice) research guidelines there is a certain standard for the conduct, design, monitoring, performance, recording, auditing, reporting and analyzing of clinical trials. This helps to offer assurance that the data and reported outcomes are accurate and reliable. It also ensures that the integrity, rights and the privacy of clinical trial subjects are secured.


Regulatory services, standards and quality assurance in clinical trials are essential, as it results in the following benefits:


* Reduces the risk

* Secures and protects research subjects

* Offers quality information and outcomes

* Results in high-quality research and good science


Regulatory services and quality assurance form an essential aspect of many CRO’s (Clinical Research Organization) in India today. The CRO’s have their specialized team for audit compliance and regulatory services that are in turn supported by an in-depth know-how of the local regulatory processes and efficient liaison with multiple regulatory agencies that ensures the efficiency in clinical trial approval process.


It has been observed that the Indian CRO’s have experience in conducting numerous audits with Indian as well as global regulatory agencies. In addition to that, they also have made study submission to various countries and include places such as MOH Israel, NPCB Malaysia and National Medicines & Poisons Board, Republic of Sudan. Some of the services comprise the following:


* Formulation of regulatory strategies

* Compilation of the clinical trial application

* Submission and follow-up of the application

* Responding to regulatory agency queries

* Procurement of drug import licenses

* Procurement of NOC for export of biological samples

* Tracking of applications and approvals

* Safety Reporting

* Submission of Clinical Safety Report (CSR)

* Renewal of Import License


The modern day biomedical technologies are superior as compared to the ones that were available earlier. As a result of which today's regulatory standards are followed diligently in various medical researchers in subjects such as medical writing, biometrics, bioavailability, bioequivalence, and other Bioanalytical studies. These apart, fully controlled clinical trials under the guidance of ethics committees and comply with the best regulatory standards are required to be conducted to set up reliable and accurate data. This data is further used to answer major clinical queries and set up the efficacy and safety profile of clinical therapy. The standard will be randomized control trials (RCT’s) in order to avert any bias and expansion to global multi-center studies will also be essential. Furthermore, this will also offer the required scientific evidence for effective and safe clinical trials. Simultaneously, the comparative medical studies that involve direct comparison with present therapies will also be required to answer some of the modern day medical concerns.


Read More About: Clinical Pharmacokinetic

Importance of Clinical Trial Phases

Clinical trials act as the key medical research tool for advancing medical know-how and patient care. These trials are conducted when doctors or medical technicians are not sure whether a new clinical approach is working well with people and is safe. Also, if they want to find out which treatments are going to work appropriate for specific illness or for a group of people.


Therefore, clinical trial cannot be considered as the first-step in developing a new drug or treatment modality. Rather, it is one of the many procedures that go into the drug development process. The research and development for the same generally starts at the bio clinical laboratories in the CRO’s (Clinical Research Organization). Post extensive research and testing, the medical technicians might test a promising drug or technique. Later on, there can be a small percentage of volunteers who are willing to participate in experimental treatments that form a huge part of the clinical trials. Depending on the result of these trials, treatments and drugs that have proved too useful they are made accessible for other extensive clinical trials.


Clinical Trial Phases


Clinical trial phases depend on the medical research organizations. Generally there are three or four phases. Some of them are discussed below:


Phase 1


This is the initial step in testing a new treatment on humans. The clinical researchers might want to study whether the ideal way to offer a new treatment is through injection, mouth or IV drip. They might also want to determine the apt dose and the number of times they need to be given to the patient every day. Simultaneously, they also look out for harmful side effects.


Phase 2


The clinical trials conducted in the Phase 2 determine whether the new treatments have an anticancer element in them. For instance, is the treatment effective in shrinking tumors and if yes, the kind of tumors it shrinks. Also whether the treatment improves the outcome of blood tests for certain cancers and not all kinds.


Phase 3


Post a treatment has demonstrated assured results in Phase 1, 2 and 3 in clinical trials, the Phase III studies compare the results of people taking the standard treatments for certain cancers in certain stages with people resorting to any new type of treatment. The researchers all over the country carry out Phase III clinical trials where many others take part.


Today well known Indian CRO’s conducts clinical trials for various medical studies that include medical writing, biometrics, Bioanalytical studies, bioequivalence, clinical Pharmacokinetic and studies dedicated to various therapeutic areas.


Read More About: biometrics companies, regulatory services, Bioavailability

Advanced Biometrics Services By CRO’s

The biometric recognition technologies records unique features of an individual. It also makes use of this data to recognize whether a person is sanctioned to do what he is claiming to do. The features that are used to make the recognition comprises elements such as handprint, vascular patterns, voice patterns, fingerprint, typing speed, walking style and much more. This data is useful for the employers into order to control the access to strategic and confidential areas. It is also helpful in enhancing the attendance and for logical access control. When utilized in an organized manner this technology can be used to enhance the productivity and minimize occurrences associated with absenteeism.


Over the past few years there have been several biometrics discoveries. The biometric fingerprint reader is one such device that helps in recognizing and using the unique set of ridges on the underside of the fingerprint. Experts are of the opinion that, even two identical twins having the same DNA might have separate prints. This device effectively captures the fingerprint image with the fingerprint recognition algorithm estimating the difference between valleys and ridges making use of a high-end sensor. To make a print it is important for the individual to roll his fingers on the sensitive area of the reader. This biometric technology is useful in securing data, for instance the USB fingerprint reader can be plugged into the desktop in order to control access to the data.


Today Indian CRO’s (Clinical Research Organizations) engaged in clinical trials have their own dedicated Biometrics team working to speed up the regulatory service and submission process, lessen the timelines through innovative thinking and offering quality services. The service portfolio includes 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

* Clinical 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


The modern day biometrics service portfolio offered by CRO’s also comprise of report writing, protocol writing and statistical analysis. Furthermore, they also use the updated software’s such as Win NonLin and SAS (SDMS & MED X view).


Read More About: regulatory services, Bioavailability

Efficient Order Fulfillment for a Successful Supply Chain

The journey through a supply chain is filled with movement and activity, and while each step is a significant part if the chain, order fulfillment plays an import role in the supply chain management and is considered as an important business process. Wikipedia defines supply chain as “a system of organizations, people, technology, activities, information and resources involved in moving a product or service from supplier to customer.” Efficient supply chain solutions manage different networks of interconnected businesses involved in delivering the products or services to the end customers.  The complexities of and the supply chain makes it important to consider the function of supply chain logistics, namely that of distributing products from one place to another.

Order fulfillment plays a fundamental role in supply chain management and many believe it to be the most important business process. Although the process differs from business to business, there are a number of disparities of fulfillment services. Right from simply shipping product to consumers to more sophisticated movements of product through a manufacturer’s supply chain, the order fulfillment process can determine how well you satisfy and retain your customers.

In today’s competitive business environment, customer satisfaction and customer loyalty are the vital aspects that determine the successful existence of any enterprise or organization. As customer retention depends on the manner in which order fulfillment is carried out, it is considered as a significant business process. Effective order fulfillment requires integration of the firm’s manufacturing, logistics and marketing plans. Enterprises must partner with a reputed service provider in order ensure customer satisfaction as well as loyalty.

Look for a service provider that can:

  • Be committed to being the best in the industry
  • Ensure customer focused team support client/customer effort
  • Have a customer cell approach to provide enhanced long-term product support, timely response, and prompt resolution to problems
  • Offer online open view tools allow instant access to all pertinent data 24x7. This allows important business decisions to be made quickly and based upon accurate data
  • Be committed to providing a safe and healthy workplace for our employees while maintaining the highest standards of environmental quality.
  • Provide Effective systems integration for conducting tests and debugging the products.

A reputed service provider will ensure that all the processes are overseen by a skilled quality control management staff that make certain that you are delivering the highest quality product to the consumer. With the right service provider your business can be assured of Lower inventory, lower overhead, more responsive supply chain design and more flexible manufacturing. 

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Global Supply Chain- Efficiently Catering a Wider Customer Base

Globalization has paved way for the growth of enterprises across geographies and with a wider customer base. To meet the ever changing demands of the large customer base, the global enterprises opt for offshore production, development and services. With the success of every business dependent on its logistics and distribution service, entering new markets has resulted in the lengthening of the supply chain.

 Wikipedia defines supply chain as “a system of organizations, people, technology, activities, information and resources involved in moving a product or service from supplier to customer.” The supply chain activities helps enterprises to deliver the raw materials, components or finished product to the customer. However, with increased globalization and offshore sourcing taking the business into new markets, management of the supply chain becomes a critical factor. Like traditional supply chain management, the global supply chain also aim to reduce costs of procurement and decrease the risks involved in purchasing activities. However, the difference lies in the fact that the global supply chain management involves the needs and interests of the worldwide customers and suppliers rather than being locally oriented.

 The organizations which were earlier focused on bare manufacturing principles for just-in-time deliveries and shorter lead times were now faced with complexity of supply lines, longer lead times and bigger batches as a result of globalization.  The challenges posed by the elongated supply lines were seen through the changes in the supply chain solutions and management strategies of the global enterprises. Further, to face the challenges and combat the competition in today’s market,   enterprises make use of technological innovations and advances in demand and supply sources and availability of information.

 The Global Supply Chain Survey conducted this year by PwC showcases that the leaders in the industry are not only customizing their supply chain but are also investing in next generation tools. The supply chain solutions for today's global markets will enable a fast and efficient supply chain system that will also cater for reverse logistics with used products re-entering the supply chain at any point with a recyclable residual value. The new age global supply chain which is built on the framework of key business process is managed by a cross-functional team.  

The leading service providers offer their clients a technology platform that supports business intelligence, customer relationship management, logistics, commerce and financial management along with real-time client reporting. By leveraging on such integrated network the enterprises can be assured of consistency and precision in their global supply chains.

 Other Links - data center integration

 

Smart Engineering Services Ensure Aerospace Develop Products in Quick Time

In an era of technology advancements, when it comes to engineering products, customers want solutions that are avant-garde and innovative. Aerospace manufacturing companies need to strive to create better models with advanced features ensure that they have an edge over all competition. It is a known fact that aerospace engineering essentially requires advanced and sophisticated tools and strategies for the designing and development of products, testing and collaboration processes. As efficient aircraft engineering is crucial to safe and comfortable flying, it is necessary for the entire aircraft supply chain to look further to their engagement with large aircraft OEMs to bring about a more robustly integrated and optimized aircraft that perform better than their predecessors and at a reasonable cost.


This can be made possible only with an extremely high degree of engineering and specialization. In this highly volatile market, enterprises that are capable of combining outsourced engineering services along with their own internal capacities are the ones that can be profitable. With reputed service-providers, it becomes easy to receive support across the entire product life cycle, as an able offshore engineering service-provider can transform your company into a global force. Engineering services outsourcing are fully capable of producing innovative and technologically advanced engineering products with proficient expertise, precision and rigor that meet the specifications and often exceed the expectations of the most challenging customers.


Efficient engineering outsourcing make use of newer technologies that are more eco-friendly, with advanced composite materials. They can help lower operating cost through cost optimization, flight safety and faster time-to-market. Leading companies in aerospace engineering are introducing innovative technical and mechanical products and solution to help the industry flourish better. They help cut product development costs, cut down lead times, extend capacity, and maximize engineering resources.


Your business can gain from a methodical approach, manage resources at cheaper costs, enhance profitability with a service provider that offers advanced engineering services outsourcing solutions. By outsourcing your engineering requirements your business can receive better, faster and more value-optimized solutions. These service providers provide proficient, robust, stable and secure solutions to ensure the completion of the entire process right from conceptualization to designing, modeling,analysis,prototyping,automation, data documentation, instrumentation and controls, embedded systems development, validation and vendor management.


Having the right materials, technology and skill is fundamental in aerospace structures. The right service provider can implement all the industry’s best practices and ensure successful generation of revenues while also meeting the demanding industry standards. Join forces with a  service provider to ensure your  businesses maintains their cost structures.


Related Links: Offshore Engineering Services, engineering analysis services

Global Trends In Engineering Services Outsourcing

The modern day engineering services sector is a growth oriented market. The present spending in engineering services is likely increase up to $1.1 trillion by 2020. The market is described to be a fragmented one. The CEO’s have been viewing overseas as a method to counter market forces that are creating pressure on engineering services. While at one hand, the cost is an issue they are also seek availability to a quality talent that can produce engineering capacity and maximize productivity. Being able to get of a quality engineering firm in such a fast evolving market also offers a chance to an expanding market of consumers and can also lessen the time to market. Whilst in FY05, the percentage of engineering services offshored was $10-15 billion; the market is estimated to increase up to $150 -225 billion by 2020.


Presently India’s share of outsourced engineering services market is approximately 12 percent, which is relatively small when compared to the figures in technology and business process outsourcing domains. It has been also researched that India is in a strategic position to increase its market share of engineering services outsourcing from 12% to 30% by 2020. However, the potential market share can also exceed $40 billion by 2020.


All these aspects, made global engineering companies foray into the country and produce innovative and technologically upgraded engineering products that needs precision and expertise and that caters to the demands of the end users. In order to reduce the production risks, today there is a need for smart engineering services. These global engineering companies offers the following services:


* Resources that substitute or augment the in-house staff

* Engineering analysis

* Design and detailing

* Manufacturing engineering

* Sustenance engineering

* Technical publications

* Special services

* Embedded systems

* Plant and process

* Eases out the cost and margin pressures

* Offers quicker turnaround time ensuring quicker time to market of products

* Works as per pre-specified SLA’s that are mutually beneficial


These global engineering service providers engineering and outsourcing solutions that come from their track record of multiple man hours of offering engineering services. This has made them come up with Global Product Development (GPD) centers for OEM’s. Over the past few years, leading companies in engineering services outsourcing has ranged from various concepts such as detailing, design and product realization solutions in the aerospace, power generation, civil structures, oil and gas, transportation and other industrial products. Their GPD’s allow them to offer value added and optimized solutions.


Related Links: engineering product development ,  Integrated Engineering Services

FBAR - Comply with Tax Laws to Avoid Penalties

Recently, a 79 year old widow pleaded guilty to filing false 2006 and 2007 tax returns. Mary Estella Curran who inherited Swiss and Liechtenstein accounts after the death of her husband, created an account with UBS in the name of a Panamanian corporation to hide her assets. She hid the income from her accounts and didn’t even bother to file Foreign Bank and Financial Account Report (in short FBAR) from 2001 through 2007.  By 2007, the accounts totaled over $42 million. As a result of which, the government lost taxes estimated to be $400,000- $1 million. Since Mrs. Curran willfully failed to report the income and file the required FBAR, she faces a penalty of 50% of the highest balance, which is $21,666,929 and a prison term up to 6 years. So what is FBAR?


FBAR is an annual report filed by Americans to report the existence of foreign bank account / accounts and other financial accounts held abroad. As per Sec. 103.24 of Reports of foreign financial accounts:


“(a) Each person subject to the jurisdiction of the United States (except a foreign subsidiary of a U.S. person) having a financial interest in, or signature or other authority over, a bank, securities or other financial account in a foreign country shall report such relationship to the Commissioner of the Internal Revenue for each year in which such relationship exists, and shall provide such information as shall be specified in a reporting form prescribed by the Secretary to be filed by such persons. Persons having a financial interest in 25 or more foreign financial accounts need only note that fact on the form. Such persons will be required to provide detailed information concerning each account when so requested by the Secretary or his delegate.”


That means any United States Person who has a financial interest in or signature authority, or other authority over any financial account in a foreign country including a bank account, brokerage account, mutual fund, trust, or other type of foreign financial account AND if the aggregate value of these accounts exceeds US$10,000 at any time during the calendar year must file a Report of Foreign Bank and Financial Accounts (FBAR).


Though the government has introduced OVDP (Overseas Voluntary Disclosure Program) to bring taxpayers that have undisclosed foreign accounts and undisclosed foreign entities to avoid or evade tax into compliance with United States tax laws, its entry is barred if the government learns about an individual’ tax non compliance from other sources.


Thus, with the IRS is becoming very strict with respect to FBAR, disclosure and finite penalties would be a better option when compared to FBAR penalties which are worse than tax penalties.


Read More About: IRS Amnesty, Tax Planning

Strategies to Protect Enterprises From Phishing Attacks

The changing technology landscape has provided enterprises with easy methods of communicating across geographies. The widely networked organizations have rapidly adopted the new age mobile devices and wireless networks to access the corporate networks and workstations from any location leading to vast amounts of digital data being transferred and stored. Though technology has provided enterprises with increased mobility and business continuity in the face of adversities, this   has also led to an alarming increase in cybercrime and security breaches. The anytime anywhere access is providing a breeding ground for organizing cyber crimes.


With highly sophisticated and targeted attacks and data breaches becoming the norm in today's cyber world, enterprises need to understand that phishing is one of the most commonly used techniques by the cyber criminals to spread malware and destruction. Phishing attacks, are attempts by the criminals to acquire sensitive information available through  the electronic communication mode. The cyber criminals use spoofed emails to trick unsuspecting employees  to share information related to user-names, passwords, bank account and credit card details. The wide use of social networking sites by the employees have also increased the chances of Phishing attacks. The techno savvy enterprises thus need to take adequate protection from Phishing attacks.


Irrespective of the firewalls and encryption software certificates and other authentication mechanisms deployed by the technologically enabled enterprises to protect the corporate network and business critical data, Phishing attacks dodges these security systems and even attack high-profile targets. The targeted information however ranges from private data  such as customer's health, credit or other personal data to corporate data  such as trade secrets, business plans and  sales forecasts. A single employee falling prey to Phishing attacks may have a negative impact on an organization's brand and reputation. This might lead  to significant financial losses in the form of loss customer loyalty and decline in shareholder value. Thus software developers and the corporate world need to collaborate to work out effective anti-Phishing tools to encounter such cyber attacks.  Further, as  the Phishing attacks go through various routes to reach the data stored in the network and IT infrastructure enterprises should also create adequate Phishing awareness among its employees.


Leading service providers of security solutions have designed and developed a diagnostic solution that can help enterprises protect their most valuable assets their employees, from becoming Phishing victims. By proactively educating the users this helps them identify Phishing attacks so they can avoid becoming bait in the future. Further, through simulated Phishing attack this solution helps capture the user's potential reaction to a real attack. By leveraging on the user's response to such simulated attacks, the solution helps enterprises generate action plans that can be implemented to avoid future pitfalls. Such anti-Phishing strategies when adopted by the enterprises will act as a line of defense against cyber criminals.


Read More About: Phishing Protection, Simulated Phishing Attack

Advantages of Advanced Anti-Phishing Software

In today’s IT landscape internet data security is of utmost importance to the majority of organizations. This is especially true with the malware and Phishing attacks, where the employees are tricked easily leading them to share their private information. This in turn results in personal and organization's losses. Therefore, the next time you receive a mail that asks for private details, it is essential that you are wary of it and know whether at all to click on the same, as it can well be a Phishing attack.

 

Defining Phishing

 

Phishing or Phishing attacks are the result of social engineering. It is a malicious strategy that is set up by third party hackers and cybercriminals for robbing your personal data. They generally appear in the form of hoax emails that take the user to fraudulent websites that ultimately cause harm to the computing device along with stealing vital information.


Why do companies need Anti-Phishing Programs?


In the modern time enterprises there are several enterprises that have encountered Phishing emails. Therefore, it is essential for Phishing awareness programs for addressing both the people and process aspect of the attacks. Today there are multiple service providers who have come up with innovative anti-Phishing software that are executed within an enterprise. The solutions too are personalized with information data regarding the processes, people and technologies that are at work. In addition to that, the social conducts towards the attacks are also assessed with a detailed analysis.


This apart, the new age Anti-Phishing software provides statistics on user behavior, and evaluates security awareness amongst the employees and identifies the data leakage. This apart, it also assists in reviewing the incident response program and evaluates the data loss prevention. Other features of the software 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

* Maximizes employee awareness and knowledge to help guard sensitive information

Therefore, by implementing a robust Phishing awareness and protection solution organizations can diagnose the security attacks and threats for a particular segment as well as the total business. Apart from this the end-to-end compliance requirements can also be managed within the risk management structure.

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