Wondering How To Meet Your Regulatory Affairs Requirements? Read This!

In the times when new regulations are formed every day and there are strict regulatory requirements, pharma companies often look for advisors to guide them in respect to legal and scientific requirements and to obtain support for marketing authorizations for various regions.

For this purpose, regulatory experts are required who can advise the right strategy that suits each phase of product development. Regulatory help is the biggest help!

Regulatory writing makes for a crucial element in medical writing. Regulatory writers work on crucial documents right from the beginning of product development, like:

• Describing and reporting clinical data
• Working on regulatory submission reports
• Generating post-approval reports mentioning the use of a certain treatment for the patients

Some of the documents that a regulatory writer works on are:

• Clinical study protocols
• Clinical study reports
• Investigator brochures
• Common technical documents (CTDs)
• Integrated safety summaries
• Clinical evaluation reports
• Patient information leaflets

A regulatory writer works on producing these regulatory documents and all the documents must have strict adherence to regulatory guidelines. They should be capable of delivering the required and desired information precisely, unbiasedly and clearly to the target audience.

Clinical Study Reports (CSR) are the outcome of a lot of hard work and in-depth research of the study teams. It is extremely important to draft well-organized and quality regulatory documents. A well-drafted CSR helps in generating high-quality submission documents whereas any CSR lacking in accuracy and clarity will result in a delay in getting regulatory approval and will cost time and money for the benefactor.

Well-experienced and trained regulatory writers are required to deal with all the necessary documents as they help in adding value in generating clinical study documents. During the process of clinical research, regulatory writers can serve as a walking encyclopedia at every step. Regulatory writers are well-versed with all the global regulatory guidelines such as Good Clinical Practice (GCP), International Conference on Harmonization (ICH), etc. and work in accordance with the preferred or required styles of the study teams/benefactors.

Regulatory writers can understand the complex scientific and statistical information and can serve as a guide to the clinical teams, including experts from various fields such as pharmacovigilance, regulatory affairs, clinical statistics, etc. They present the information in an organized and simple manner for it to be understandable. They interpret the results and are in charge of presenting clear and unbiased conclusions.

Why go for outsourced regulatory services?

Regulatory affairs are very crucial, and many firms hire regulatory writers via outsourcing. When deciding whether to outsource your regulatory writing team, cost analysis plays a major role. It is essential to present complex information/data clearly post accurate interpretation within the strict and short timelines. In such a situation, outsourcing experienced regulatory writers can be a wise option as it will help to maintain the quality of documents and will also eliminate the risk of failed submissions within the timelines.

By tapping onto the resilience of the expert team of regulatory writers, who are well-aware of the recent guidelines, work efficiency is promoted for your organization as your deliverables will have timely submissions and it can also prove to be cost-effective. The ever-changing publication demands can sometimes increase the workload on your in-house team, and you might struggle to get the work done and hiring a full-time team of regulatory writers might not be the wisest option, cost-wise. By outsourcing skilled regulatory writers, you can cut the extra cost and get your work done efficiently.

Outsourcing writers exposes your organization to a greater docility and by maintaining long-term relationships with outsourcing firms, you can get your work done in future too.

Turacoz Healthcare Solutions equips with a dynamic and highly skilled team of regulatory writers who are always committed to deliver projects timely and with strict adherence to all the guidelines. The regulatory experts can provide you with strategic advice and take full responsibility of producing regulatory documents.

Turacoz extends its support to pharma and healthcare sector in various ways:

• Regulatory affairs & consultancy
• Regulatory writing
• Safety reporting

Turacoz has expertise in delivering pre and post-approval submission documents, QC (Quality check) & QA (Quality Assurance) projects. The dais that we work on is quite large, covering drugs, generics, biosimilars, biologics, diagnostics, biologics, medical services, immunology, etc. The ICH-GCP and country specific guidelines and templates are kept under strict consideration while working on the documents and it is ensured that the documents submitted are of high quality.

Turacoz Healthcare Solutions is a medical communication firm, dealing with services like medical writing, publication writing, pharmacovigilance support, regulatory affairs, real-world evidence, medico-marketing and clinical trial support. To know more about our services, you can get in touch with us at hello@turacoz.in

Quick and Easy Fix for Your Clinical Trial Requirements!

Exploring new dimensions and working towards new advancements defines the science today. Numerous experiments, innovations, inventions and researches are the faces of science in the modern era. With such fast-paced development in treatment of various ailments, backed by the advanced technology, many drugs have surfaced which are expected to treat certain diseases.

Clinical trials are the result of all these researches and quest for innovation and advancement in medical science.

What are Clinical Trials?

Clinical trials are scientific investigations carried out to discover better approaches to avert, screen for, analyze, or treat illness. These trials may likewise indicate which medical methodologies work best for specific sicknesses or group of individuals. Clinical trials create excellent data for healthcare decision-making.

The motive behind clinical trials is to answer scientific queries. In this manner, these trials pursue strict, logical guidelines which secure patients and help deliver dependable clinical trial outcomes. Clinical trials are one of the last phases of a long and watchful research & development process. The procedure usually starts in a lab, where researchers initially generate and test new ideas.

Phases of clinical trial:

Clinical trial is divided into 4 phases. These are explained as under:

• Phase 1: Testing of an experimental drug, device or vaccines on a small group of individuals to get a hang of the safety, possibility of side effects and evaluating how the drug should be given.
• Phase 2: A larger group of people is set off to experimenting the safety and efficacy of the treatment and this procedure can last for many years.
• Phase 3: This is an extensive study involving many participants. This is the comparison phase where the new/experimental drug or vaccine is compared to a placebo or existing/standard treatments. Some side effects that might go unnoticed during Phase 2 trials, can be discovered during this phase. The regulatory authorities will consider the trials up to this phase and will decide upon the approval of the new drug.
• Phase 4: This phase is the last one and comes into the picture post approval of the drug by the regulatory authorities. The drug’s safety and efficacy are observed on diverse populations.
  

With every clinical trial, a protocol is associated, which informs that what is to be done in the trials, how many phases are to be conducted and which one would be the most important one. These protocols also include guideline or eligibility criteria describing who can attend a clinical trial.

There are a lot of documents involved in the whole process of clinical trials. The entire cycle of drug development includes planning a clinical trial, preparing various documents both pre-& post trials in accordance with country-specific guidelines, submission documents and safety reporting.

The issue faced here is to get such a team of skilled and expert professionals who can handle the documents carefully and work on them with the required expertise and knowledge. This is very crucial for any Clinical Trial Organization (CRO) or pharmaceutical organization.

Here is a quick fix to all your troubles related to clinical trial documents: Turacoz Healthcare Solutions.

Turacoz Healthcare Solutions is a medical communication company offering various medical writing services, pharmacovigilance support, medico-marketing and publication services. It has a highly skilled and dedicated team of expert medical writers who work on a variety of medical documents including clinical trial documents.

Turacoz has a dedicated team of clinical research experts who are proactive at handling various clinical trial documents like informed consent forms, protocols, investigator brochures and clinical study reports for each phase of clinical trial in any therapeutic area.

Get your work done by experts at Turacoz and rest assured for the quality and timeliness of the documents. Turacoz believes in delivering quality output to the clients and supports prompt delivery of work.

To know more about us and our services you can get in touch with us at:
hello@turacoz.in
We will be pleased to help you.

Getting a hold of Real-World Evidences was never so easy!

The world of pharmacy today is full of new drug innovations and enhancements. Various drug manufacturers are coming up with new medications for various ailments and want to get it approved for use. Whenever a new drug is produced, before it is sold into the market, it has to go through certain approvals by regulatory authorities to ensure that it is safe for consumption and is effective in the treatment of the ailment it is meant for.

Clinical trials though, are conducted to validate the efficacy and safety of a drug but, these trials are conducted are in a controlled environment. Before the drug is out in the market, it is very important to know how it functions in an uncontrolled environment, i.e. the real world.

We have to comprehend the job of a medication in enhancing patients' results and what all variables come into the image. This calls for the “Real-World Evidences.” It gives you bits of knowledge on different angles like drug safety, pharmacoepidemiology, health economics, and research results and aides in effective decision making.

Real-world evidence (RWE) and Real-world data (RWD) are assuming an expanding job in healthcare decisions.

• Food and Drug Administration (FDA) utilizes RWD and RWE to screen post market safety and unfavorable events and to settle on regulatory decisions.
• The healthcare sector is utilizing this information to support coverage decisions and to create guidelines and decision support tools for use in clinical practice.
• Therapeutic device manufacturers are utilizing RWD and RWE to help clinical trial structures (e.g., extensive straightforward trials, pragmatic clinical trials) and observational examinations to create inventive, new treatment approaches.

What is RWE?

It is the clinical proof regarding the use and potential advantages, or dangers of a therapeutic product derived from the examination of RWD.

What are RWD and where do they originate from?

These are the data identifying with patient wellbeing status as well as the conveyance of medicinal services routinely gathered from an assortment of sources. RWD can originate from various sources, for instance:

• Electronic health records (EHRs)
• Product and disease libraries
• Patient-created information incorporating into home-use settings
• Claims and billing exercises
• Data accumulated from different sources that can advise on health status, for example, cell phones

Real-world evidences go through the following issues and address them:

• Fiscal strain of a disease
• Advantages of a new intervention & its commercial connotation
• Additional cost of a therapy: risk vs. benefit
• Assessing new treatment vs. existing alternatives

These assessments are eventually converted into clinical, financial, and humanistic results of a treatment. The current circumstance requests RWES to completely comprehend the estimation of a product and its potential in real-world clinical practice. Assessing a medication just on the premise of its viability and safety is not anymore adequate to dispatch a product for clinical use.

Eliminating your worries on real-world evidences with Turacoz Healthcare Solutions:

Turacoz Healthcare Solutions, a medical communication company, be in cahoots with the clients to offer RWEs that aids the pharma products throughout their entire life-cycle. We have good record of working on various such studies for our clients, all over the globe.
Turacoz offers the following services in respect to RWEs:

• Data collection
• Data investigation/analysis
• Report writing
• Publication

The process comprises of end-to-end support for observational studies, epidemiological & retrospective studies and registries.

Apart from RWEs services, Turacoz also provides following services at the global platform:

• Medical writing
• Regulatory writing
• Publication writing
• Pharmacovigilance support
• Medico-marketing
• Clinical trial support

Turacoz has highly dedicated team of skilled professionals who deliver the best of services within the required time frame. You can rest assure after handing over your work to Turacoz.

Here is a quick cure for Medico-marketing

In the world of constant innovation there are a variety of things manufactured which are then marketed. There have been a lot of advancements in the field of science and medicine. Various drugs are invented for various ailments and various medical devices are manufactured. Drug manufacturers actively seek for medico-marketing solutions.

What is medico marketing?

Medico-Marketing is a procedure of information exchange that occurs between a drug producer and the consulting specialist, Nurse, Pharmacist or with the patients. The goal of this is to clarify the organization's products and how it will help the customers in forecast or treatment of the health-related issues.

This information exchange is oriented towards sales. However, the description made must be very clear and precise and the sales process must be defined clearly as the product can be hazardous if used in a wrong manner.

The effect of medico marketing depends on the techniques and strategies used, up to a huge extent. An efficient medico-marketing plan will work on the following elements:

• Constituting an objective
• Recognizing the target group
• Formulation of a road map to achieve the goal
• Investigating the marketing plan at frequent intervals to track the progress

The pharmaceutical industry is changing dramatically, and India is establishing itself well as pharma manufacturers. In the case of pharma products, the consumers are the patients, but they are not exposed to the choices and it is the doctors who decide for any particular drug, thus doctors end up becoming the actual customers.

Selling products to the experts/specialists require an extensive knowledge base so that that the product and its USP are sold. The documents involved in medico marketing are essential for both commercial and scientific use. Well-planned and crafted medico marketing documents help spreading awareness regarding the product and diseases for patients as well as healthcare providers.

At Turacoz Healthcare Solutions, we understand the need for marketing in today’s era. Turacoz is a medical communications company which provides you with a wide range of services including medical writing, scientific writing, publication writing, regulatory writing, pharmacovigilance support, real world evidences and medico marketing.

Medico-marketing support at Turacoz:

Turacoz Healthcare Solutions offers customized medico marketing services. We extend our support to healthcare, pharma, biomedical companies and medical device manufacturers along with doctors, hospitals and patients.

Turacoz devises the medico marketing strategies and plans keeping in focus the target audience. The highly dedicated team of experts extends end-t-end support to the clients. We cater according to the requirements of the clients and offer the best possible solution.

Turacoz team shoulders entire responsibility of formulating the plan for the chosen strategy, KOL (Key opinion leaders) coordination. The classy and innovative designs fit accordingly with the marketing strategy.

Below is the list of medico-marketing documents that we offer:

• Product monographs
• Newsletters
• Slide decks
• Patient education material
• Leave behind literature
• Visual aids
• FAQ booklets
• Training manuals
• Customized booklets and books

Turacoz believes in serving their clients the best and work upon the same. Any of your medico marketing problems and we are ready with the best solution. To get the assistance you can get in touch with us at hello@turacoz.in

Turacoz Healthcare Solutions is always at your call, ready to assist you in achieving your endeavors and goals.

Got Stuck? Join Hands with Turacoz to Streamline your Pharmacovigilance Process

Whenever there is a new drug on the market the biggest question surrounding it is about its safety and any possible adverse effects. Drugs are created for the safety and betterment of human lives, so it is very important to be sure of the usage of the drug, its side-effects, etc.

This is where Pharmacovigilance comes into the picture. If you are a pharma company/drug manufacturer, you might want someone to offer you with pharmacovigilance support.

Pharmacovigilance deals with 2 main aspects:

v  Safety: how safe is the drug for consumption & how they work on patient.

v  Potency: how effective is the drug in treatment of various diseases and what effect does it has on patients.

What is Pharmacovigilance?

Pharmacovigilance is also known as ‘drug safety’. It includes assembling, inspection, controlling and interception of adverse effects of drugs & therapies. This is a scientific and process-oriented field in the pharmaceutical world.

It is concerned with every facet of drug development-course, starting from pre-clinical progress to post-market control. This establishes pharmacovigilance as the bottom edge of a life sciences firm.

What is ‘adverse event’?

The ‘adverse event’ for any drugs is the side effect that a drug has on human body. When a drug reacts with the human body and creates a negative effect, then it can lead to serious & dangerous effects on health and a patient might have to go through hospitalization, immobility, permanent impairment or even death in the worse scenario.

It is compulsory for all the clinical trial research auditors to report the adverse effects of the drugs even if there is only a speculation or doubt.

The role of pharmacovigilance is to learn whether the side effects of the drug are within the accepted limit as compared to the usefulness of the drug. In simpler terms, it assesses whether the effectiveness of a drug in treating a disease is worthy enough to let slide some side effects it causes.

Why is Pharmacovigilance so important?

v  It plays a crucial role in drug development. If a company wants to develop, synthesize & commercialize its drugs then it must stick to the rules & regulations. These regulations ask for the efficiency of a drug, its advantages & other benefits for the patients.

v  The main aim of pharmacovigilance is to access drug- and patient safety. Drug safety ensures that the drug does not cause any unwanted and negative effect on the patients during the drug development cycle or when it is ready for sale in the market.

v  Drugs are constantly kept under observation for any side-effects on patients & any new data if generated is organized and handed over to the health authorities at frequent intervals.

 If you are a drug manufacturer/pharma company & looking for pharmacovigilance support, then Turacoz Healthcare Solutions is there to help you.

Turacoz is a medical communication company which provides with end-to-end pharmacovigilance support, from literature monitoring to case processing. It also provides consultancy facilities for pharmacovigilance.

 Turacoz provides the following services related to pharmacovigilance:

v  Construction of entire pharmacovigilance unit

v  Pharmacovigilance voice process support

v  End-to-end case processing

v  Signal disclosure

v  Literature research

v  Reporting of adverse cases

v  Safety report generation

v  Pharmacovigilance Training

Turacoz provides the best of pharmacovigilance support to its clients and extends its full support in all the related activities just to make sure that all the requirements are met efficiently & effectively.

So, if competent Pharmacovigilance support is your concern, reach out to Turacoz Healthcare Solutions for assistance.