Medical writing and Regulatory Affairs from WorkSure

WorkSure A First Medical Service KPO in India is a consultancy organization providing services to Healthcare companies within the Regulatory Solutions, Technical, Medical Affairs, Phamacovigilance and other fields. WorkSure is highly skilled and offers strategic and operation experience combined with company know-how and its strategies, ensuring the rapid fulfillment of excellent results.
The services range from regulatory affairs to preclinical and clinical scientific research, statistical solutions etc. WorkSure ensures efficient support across all areas like medical writing and procedural assistance during the life-cycle of products. WorkSure can also help in editing and review of sponsor prepared documents, SOP preparation and from bio-pharmaceutical studies to initial phases of clinical testing.
WorkSure direct interaction with Regulatory Affairs, Technical Production, Medical and Marketing Departments ensures high level competence, speed and operation flexibility. Also, they co-operate with the Management and other departments involved in the project to enhance and develop the company portfolio.
Why outsource to WorkSure?

Most companies have adapted the outsourcing strategies that allow maximum flexibility of structuring, minimizing their costs and integrating the company know-how with the skills and capabilities which are specifically hired for individual projects helping management to focus their time, energy and internal resources on strategic activities.
The relationship between the Client and WorkSure is based on trust, mutual understanding as well as working professionalism and the SOP’s we follow. Once the relationship is established, the Client can rely on a professional outsourcing service that is qualified in multiple areas (Regulatory Affairs, Pharmacovilance, Medical Writing, Research Solutions, Pre-clinical and Clinical Trials) and as the need be.

How outsourcing can be a useful activity?

a) You receive trained professionals to do your job without requiring hiring a trained staff or training the internal staff. b) You get the work done from the specialized professionals in strategic areas for the company without require additional resources.
c) Commitments for a limited period and do not require to you recruitment an internal personal.
Worried about certain activities becoming a problem for your company? It is time to consider outsourcing. You decide what you want to outsource and when to do it. WorkSure plays a key role in this respect and can help you plan the most effective service modalities with its experts, in accordance with your needs.
Regulatory Affair Services

WorkSure Regulatory Affairs covers a wide variety of different areas helping companies across the pharma and related industry sectors in helping them manage their daily regulatory affairs along with additional activities which need specific expertise or additional resources. These activities can be partially or fully outsourced.
The primary services include

Medical consultant representation at National Regulatory Authority meetings
Preparation of Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND) & New Drug Application (NDA)
Render support for preparation of medical device submissions eg 510(k) and pre-market approval documentation.
Risk Management Plan / REMS (Risk Evaluation and Mitigation Strategies) and other regulatory documents for clinical trial and drug marketing approval.
Preparing prescribing information, product monographs and product labeling

The advantage of WorkSure Outsourcing resides in its integrated know-how derived from the experience and knowledge in multiple areas by its staff over the years of work and outsourced projects. This know-how is utilized for the clients by the project leaders who can always count on team work and constant support.

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Pharmacovigilance Services from WorkSure

Life Sciences companies need the operational burden to be taken away so they can focus on the science of safety. They need flexible, scalable operations that run like a well-oiled machine while achieving quality and efficiency objectives. Compliance should be “business as usual” so companies can concentrate their attention on strategic safety governance, benefit-risk management and proactive safety surveillance.

It is possible to avoid the growing operational problem by moving toward an externally managed solution that consistently and routinely achieves required business outcomes using a globally integrated model. As your partner, WorkSure will deliver Pharmacovigilance outsourcing services through a global operation with an unprecedented compliance record—no critical findings from audits and inspections by clients’ QA and the regulators.

WorkSure helps the Life Sciences industry achieve better pharmacovigilance through regulatory compliance, higher productivity, higher quality and strategic safety outcomes.

Match the solution to the challenge

The need for PV outsourcing is a reality for most Life Sciences companies. As we have implemented these services for our customers, we have adapted according to their operating models, outsourcing maturity level and the scale of the challenge being tackled. We achieve a competitive price point by leveraging our offshore delivery network, and we offer a range of services that can be tailored exactly to match the demands of any context:

1. Discrete, specific need: Services to augment a PV organization’s existing operations using its own systems and processes; additional capacity provided as needed, with direct oversight of a flexible pool of outsourced resources.

2. End-to-End Pharmacovigilance: Fully managed service spanning end-to-end pharmacovilance services, integrating seamlessly and using a pharmacovilance organization’s systems and processes; strengthened through our advanced operational excellence capabilities and analytics capability.

3. Next-generation solution: Fully managed service spanning end-to-end PV services, integrating seamlessly and using a PV organization’s systems and processes; strengthened through our advanced operational excellence capabilities and analytic capability.

Build in quality and mitigate the risk of change

Every project does not have to be a large-scale transformation. If you require tactical cost reduction with rapid implementation and the associated control and flexibility, we excel with this model. If you are embarking on a game-changing pharmacovilance transformation, however, introducing our services can be a significant facilitator of that transformation. We will help you drive your vision forward.

People—patients, healthcare professionals, policy makers and your employees—are at the heart of pharmacovigilance. Our change management and communications experience will help mitigate the risks of adopting new methods, letting you focus on the strategic vision and realize the ultimate patient safety benefits.

Lean, efficient processes, controlled through compliant standard operating procedures, are the backbone of every service we deliver. We can help you to simplify your global workflow with high throughput, replace manual steps with automation, and build in quality to help you get things right the first time.

Building the future success to Pharmacovilance

WorkSure is deeply committed to helping pharmaceutical companies address current challenges as well as pre-empt future issues. Through WorkSure accelerated services, we bring the next-generation, fully integrated business service that delivers optimized processes across the clinical, regulatory and PV functions around the globe. This solution, supported by outsourced operational activities and enabled by customizable technology platforms, helps pharmaceutical companies bring drugs to market faster, at less cost and with reduced execution risks.

Further, the solution is leading edge, supporting maximum efficiency in R&D as well as the management and measurement of R&D processes. Advanced data analytics drive innovation across companies and help release the full value of the data. By adopting an externally managed solution that consistently and routinely achieves required business outcomes using a globally integrated model, phamacovigilance organizations will gain the freedom to focus on the science of safety.

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Role Of medical data management services and medical affairs services

Clinical data management is a multidisciplinary process which involves collection, integration and validation of clinical trial data in accordance with regulatory standards. It plays a crucial role in clinical research and generates high-quality, reliable, and statistically sound data.

CDM also reduces the time frame between drug development and marketing. The primary aim of CDM process is to produce high-quality data with minimal error rate. CDM process encompasses Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking.

Several software tools are available for managing clinical trial data and these are called Clinical Data Management Systems (CDMS). Commonly used CDM tools are ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite. Among the open source tools, the most prominent ones are OpenClinica, openCDMS, TrialDB, and PhOSCo. These CDM software are available free of cost and equally good as their commercial counterparts in terms of functionality.

The CDM tools also enable to maintain audit trail of medical data management activities during the clinical trial and thereby help in avoiding discrepancies. Multiple user IDs can be created for each team member with the help of these tools. This assures access only to the function allocated to each user ID and does not allow any other changes in the database. In cases where changes need to be made in the data, the software will record the change made, the user ID that made the change and the time and date of change, for audit purposes (audit trail).

It is mandatory to follow good practices in CDM and the electronic records have to comply with Code of Federal Regulations (CFR), 21 CFR Part 11.

Presently, best CDM practices have evolved due to the increasing demands from pharmaceutical companies as well as from regulatory authorities in order to generate high quality data. On the other hand there has been a shift from the paper-based to the electronic systems of data management. There has been a positive influence of technology development on CDM process and systems. CDM should be evaluated through systems that have been put into practice.

All around the world, company is serving clients with tools in domains like Medical Writing and Research Solutions, Preclinical Clinical and Scientific Research, clinical trials, medical writing training, medical affairs services, medical data management etc.

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Clinical Research Coordinator - Roles and Responsibilities

Clinical Research Coordinator (CRC), research coordinator or site coordinator is a specialized professional who assures uninterrupted and ethical conduct of a clinical trial at institution/hospital. AlthoughPrincipal Investigator (PI) is largely responsible for proper conduct of a clinical study; CRC shares the onus by working in coordination with PI under his supervision. Like PI and co-investigators; the CRC is an integral member of the team who performs clinical trial in accordance with regulatory guidelines and institutional requirements. CRC acts as an intermediary between trial subjects, institution and sponsor on ethical, personal and financialaspects of trial. Largely, CRC remains involved in almost every step of the study.
Clinical Research Coordinators performs the following activities:

1. CRC collects the updated and signed resume of each member of the investigator team. He/she ensures the timely completion of pretrial documents including form 1572, financial disclosure form, undertaking from the PI and confidentiality non-disclosure agreement.
2. Helps PI in determining study feasibility questionnaire and maintaining liaison with the study sponsor.
3. Assists PI in recruiting subjects as per the inclusion and exclusion criteria predefined in study protocol.
4. Participates in informed consent process and ensures that all the trial related questions of participants are answered to their satisfaction. He/she obtains duly signedand dated informed consent forms from subjects. Furthermore, he/sheensures that amendments to consent forms are appropriately implemented and signed.
5. Monitors day to day progress of trial and reports to concerned authorities.
6. CRC ensures timely conduct of protocol specified investigation of subjects. CRC also makes sure that specimens are properly labeled, packed and stored before shipping them to labs. He/she keeps track of the reports obtained from laboratories.
7. Collects generated data as per pre-specified protocol and assures timely completion of Case Report Forms.

1. Performs inventory management and ensures adequate and continuous supply of investigational drugs/devices and other required materials.
2. CRC maintains study documents, records and files in accordance with sponsor requirements including but not limited to, consent forms, source documentation, narrative notes etc. Moreover, he/she retains these records as per institution/sponsor requirements for specified time period.
3. Assures effective and ongoing communication with sponsor, research participants and PI during the course of the study.
4. CRC coordinates with investigator, sponsor and IRB/IEC to confirm the conduct of trial in agreement with regulatory requirements.
5. Actively participates during the monitoring visits, audits & inspections by the sponsor’s representative.
6. CRC confirms that study gets completed as per the specifiedtimelines
7. Once the study is closed, CRC maintains the inventory of archived documents.

Thus CRC plays a pivotal role in various activities like conduct of the study, protection of human subjects and eventually successful completion of study. Considering steep rise in number of clinical trials and their overtly complex designs, an expert and well trained CRC has become an obligation for sponsors. Thus, proficient CRCs are integral to the safe and effective performance of clinical trials.

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KOL Management in Medical Writing and Research Solutions

KOL is shorthand for Key Opinion Leader, a term used to categorize the professional doctors, medical service suppliers, and teachers who lead the medical group in improving better public wellness through research, posting, and medical practice.

As medication and life-sciences companies search for the most useful, good ways to handle cooperation with the doctors who perform research, create articles, or talk with deal with, connection control of the connections with these best doctors, or KOL Management (KOLs), has eventually appeared as individual business self-discipline. Similar to CRM, KOL control is an important element for promoters and medical team right through the life-cycle process of a particular medication or product.

By beneath a company process that makes and preserves significant and collaborative connections between KOLs and company features from marketing to medical organizations, drug and life-sciences companies can information improved discuss of speech and multiplied adoptions at the international, nationwide, and local levels.

Heart of KOL and Medical Affairs Services
As doctors do your best to choose from a numberless of medication options for their sufferers, they often turn to other key viewpoint innovator doctors for information and advice on certain medication. KOL Management enjoys a unique reliability, as their credibility often arises from years of market experience and medical connections. As a result, medication and life-sciences companies have started depending intensely on key viewpoint control to help set up the understanding about their medication and increase their marketplaces throughout all levels of life-cycle control.

The Upcoming of KOL Management and Medical Writing and Research Solutions
The effect of KOL on product or medication adopting is indisputable. Such as, the mutually beneficial, mutual relationship between a pharmaceutical or life-sciences company and its KOLs is important but critical to manage properly to maintain company and physician independence at every point. As medication and life-sciences companies keep catch the fantastic positive effect that KOLs have on their company, KOL management will keep growing and create as company behavior with training that could convert to key connections in other sectors.

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Medical Writing Training Course Benefits In Medical Data Management

Digital wellness information are very popular and in demand in healthcare methods these days. Many methods these days, such as medical data management services use this application for saving all their information.

There are a few individuals who are frightened about using electronic permanent healthcare record application for saving their healthcare information as they worry that it may contain insects that harm its performing and delicate information.

Then again, there are also many individuals who prefer choosing Medical Affairs Management Services for their electronic healthcare information as they feel there is nothing better than digital certification. This information is called EHR systems, where the best system offers various benefits over document healthcare information.

Advantage

The main benefits are that it accelerates the individual certification procedure, such as their bills and medical concerns. Moreover, it makes sure the information is more precise as there is no chance of uncertainty going on in hand-written segments.

If needed, semi-automation is also used for boosting up the certification procedure. Moreover, healthcare methods that have electronic information provided by wellness information control solutions are much easier for the auditor to call up for appropriate information when they have to evaluate it. 

It’s not practical to expect all your proper care needs to be taken proper at a single medical center. If you are known as another doctor to address your heart related illnesses, you have to take along your current healthcare information to show the new specialist. In situation of document information, the necessary records have to be recovered and couriered to the new location.

However in situation of electronic healthcare information, the facts can be safely and immediately sent to the new specialist. Or if needed, the doctors in other places can access the appropriate information available just by writing a security password and obtaining the wellness information control solutions network.

Helps preserve money

Though smaller healthcare methods find it needless implementing EHR application, they can definitely benefit through wellness information control. They can preserve on document cash, choosing part-time employees to manage all this information and processing resources for all their document information. In fact, in some cases, individual privacy is also improved because of this as it’s difficult for electronic healthcare information to get lost or utilized by the wrong individuals. 

While looking for the right wellness information control solutions for your healthcare office, choose something that’s easy for your employees to work and associate with. With the right solutions, everything related to payments, confirming and even invoicing because simple that allows improve your efficiency.

WorkSure™ MedPharma Consultancy India Pvt. Ltd. is a full Clinical Data Management Services (CDMS) based in New Delhi, India. Our main focus is to provide Data Management Plan,  dcf generation, statistical analysis, medical coding services,  medical writing support to pharmaceutical, biotechnology and medical device companies.

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Five Most Efficient Steps For KOL Management

For companies from the pharmaceuticals, biotechnology along with medical devices field, the existence along with role of Key Opinion Leaders (KOLs) is a matter of critical significance. To experience reliability out there and improve their own business, these creditors need to employ and set up successful connections with KOLs. This area of KOL control is relevant to CRM often. Just as businesses should fulfill the needs in their clients, it is also important to fulfill KOL Management who is able to have a main effect in building a popularity and demand because of their items out there.

Optimal control of connections with KOLs is important for the success of your item. It is important kid recognize potential commanders before they acquire popularity and entire reliability, if an administrator can create a good relationship with a personal before they become an important figure in the career, this will create sure a strong connection. Here we have a look at 5 important methods effective KOL control might be assisted through the clinical data management services:

1 Alternative KOL profiles

CRM application is employed to draw out finished client details associated with targeted promotion. Furthermore, they point out leads and sales possibilities to create the most of. Supervisors can create use of this in KOL features by including particular information on important opinion leaders to build extensive KOL pages. With particular details at hand, one can plan particular techniques to deal with different KOLs. KOL store program will carry complete details regarding each KOL, from contact information to past record with all the organization and brand. An impressive CRM program will enable users to produce a main data source of guides, records, URLs and video clips connected to KOLs through the Material Collection. Admission to public details through public CRM is definitely an extra basically by allowing real-time use of content published basically by KOLs.

2 Improve relationships

CRM application information personal information upon clients and choose this details available as and once needed. Furthermore, it can draw out connections in this particular information which may have been indecipherable otherwise. The similar can be used in KOL features. Every key opinion innovator will probably be handled on anyone foundation. This reduces an opportunity of connection mismanagement by creating the task much more effective. Factors such as changes out there and KOL might be outlined easily to create sure that these may be resolved on a positive foundation. Furthermore, the CRM remedy assures efficient activity features by guaranteeing open/ shut projects and prearranged sessions are available below appropriate information.

3 Ensure company-wide adoption

CRM offer ideas to accomplish adopting of your specific system associated with handling KOLs throughout the organization. It is important experience a main data source of appropriate and important KOL details, which is often safely utilized basically by workers across almost all features from different places. From Marketing to research & Development, every function could require important home KOLs to create business choices. CRM alternatives furthermore accomplish creation of signals or administration guidelines to avoid several workers from calling the similar key opinion innovator.

4 Determine relevant KOLs

One on the greatest advantages of CRM application is its potential to draw out only probably the most appropriate details, as and once needed. This can be very useful to eliminate all needless details while working with particular circumstances. Sometimes you might just need a targeted research on the KOL information to produce a precise decision. CRM provides the foundation for such research. In case of your particular drug or maybe item test, you can emphasize the relevant KOLs. This can especially work on times of problems to separate the key KOLs for that period.

5 Evaluate real-time info

At the end on the day, the goal of KOL control should be to offer relevant details to appropriate men and women or positions every time needed. CRM application along with KOL Management features offer real-time reviews that may accomplish precise choice creating by quantifying along with collating details. For example, CRM reviews will help managers study specific reviews on all activities connected to KOLs for a particular period of your energy and effort with their relevant position along with due schedules.

Establishing and maintaining KOL connections might be complex, the least mismanagement can effect on the organization's qualifications so because of this on the need and adopting in their items. Applying a CRM answer increases KOL features and guarantees enhanced reliability for items and services.

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Advantages of Clinical Data Management Services

Life sciences and healthcare expertise worldwide have reached at a stage where every individual gene and its functionalities are being researched. Currently the era is of methodical research and disciplined selection of information from sample research and testing of various examples ranging from microbiological to individual sufferers. Any scientific research needs many candidates and individuals, who can be studied, thus help create a data source that can be mathematically analyzed and information can be generated to come up with a precise solution for the topic under test. along with the lines of fingerprint scientific research forms a strong foundation that enables Clinicalresearch organization to obtain vital information, mathematically analyze and identify individual traits that are undergoing phase tests depending on intrinsic and physical factors.

Clinical Data Management Studies is also called as CDMS, and as the name itself suggest the literal meaning of the term. Simply put, it means storage and maintaining information and information of sufferers.
Clinical data management services is a system which helps to monitor health information and also the essential financial information of sufferers under study. Thus it saves a lot of manual workload and become a single data source which comprises of all the important information about the examples and topic that are under testing procedures. Biometrics information exploration is the method of finding the patient's information from the stored information, posing queries and extracting essential information from the data source to find a better and precise results pertaining to the research undertaken. The terms biometrics was basically correlated with research as fingerprint scientific tests were centered on selection of lots of mathematical information which was collected during different phases of drug development for healthcare illnesses. There are numerous scientific research companies that have initiated fingerprint scientific research solutions to provide a confined mathematical research and evaluating the effectiveness of drugs/medical methods in line to be commercialized.

To summarize healthcare information control shortens the time and energy required for carrying out elaborate scientific research process. The new protocols can be easily modified and included in the existing systems. CDMS along with biometrics information exploration is rapidly becoming more popular in many companies that undertake scientific research solutions.

With effective fingerprint scientific research and methodical approach during fingerprint scientific tests a CRO proudly gains an edge over its counterparts. India also has many centers offering fingerprint and healthcare information control solutions to attract big pharma companies to invest in them. Worksure MedPharma Consultancy is dedicated to offering biometrics solutions internationally for Biometrics scientific tests, Biometrics scientific research and Biometrics information exploration.

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