What Are Clinical Trials? How To Get Writing Support For Your Clinical Trials?

Making our living better and comfortable is what science trying to do since ages. The well-being of human race is what the new inventions and discoveries in medical science are focused on. There are various diseases that have been taking a toll on human lives and making survival difficult. Medical science, over the years, has discovered cure for numerous diseases. Further, constant efforts are being made to discover cure for diseases that remains uncured and to find better treatment strategies for existing ones.

Clinical trials, being one of the parts of these efforts, are aimed towards finding/developing new and better treatments for various ailments and help patients all over the globe and enhance human health.

What is a clinical trial?

Clinical trials are explained as the scientific studies which are organized with a focus on preventing, screening, diagnosing and treating various diseases. These trials show that which treatment would be the best for an ailment/ disease in group of people.

Clinical trials aim to answer the scientific questions. Clinical trials, therefore, follow strict protocols and scientific standards and guidelines so that the patients are safeguarded, and reliable clinical trial results are generated.

New ideas are developed and tested under lab conditions after which they are tested in clinical trials. Clinical trials thus fall under the final stage of prolonged research and development process.

Clinical trial phases:

Clinical trials are divided into 4 stages. Each stage/phase holds its certain importance and a distinct purpose. Below mentioned are the four phases of clinical trials:

Phase 1: This is conducted on a smaller scale, probably a smaller group of people, to test an experimental drug. This is to assess the safety levels of a drug or treatment.

Phase 2: This phase involves more people than phase 1. The experimental group is bigger, and the tests are conducted to assess whether the drug/treatment is effective or not.

Phase 3: This phase includes conducting of experiment on larger group of people. Here, the experimental drug is compared with a placebo or standard treatment and then the safety and efficacy of the drug are evaluated. The potential side effects of the drug, that otherwise go unnoticed in phase 2, can be detected at this phase as the group being experimented on is larger. If the drug being tested is found to be more efficient and effective than the existing ones or placebo, it is further presented for FDA approval.

Phase 4: Post the phase 3 trials, a drug is either approved or rejected. The phase 4 begins when FDA approves a particular drug. The drug’s efficiency and safety are then assessed in diverse population.

Every clinical trial has a fixed protocol and plan that state that how a clinical trial would be conducted, what will be done in the trials and why every phase is important. The protocols also include the information and rules about the people participating in the trials and mentions that who cannot participate in the trials.

There are various documents associated with clinical trials which are to be sponsored and monitored in accordance with GCP (Good Clinical Practice) and all the required regulatory guidelines.

Good and efficient medical writers are required to work on these documents and most pharma and healthcare companies, and clinical research organizations struggle to find efficient and skilled medical writers who can generate the required documents in a systematic fashion.

Writing support for clinical trials:

Turacoz Healthcare Solutions has a dedicated team of medical writers who are highly skilled in their work and efficiently produce the required clinical documents in the given timelines. The dynamic professionals here have expertise in developing protocols, clinical study reports, informed consent forms and investigator brochures for each phase of clinical trial and in all the key therapeutic areas.

Whatever your requirements are in documents related to clinical trials, we provide you with the same. Turacoz team also hold experience in producing clinical trial disclosure documents and are updated regarding the various guidelines by the regulatory authorities.

To avail our medical writing services and to know more about our services and offers, write to us at hello@turacoz.in

To be a part of the Turacoz team and shape your career in medical writing, click here.

Employees’ Day Out: A Trip to Camp Wild

Jack is an office worker

Jack is a workaholic

Jack never plays and doesn’t have fun

Jack leads a monotonous life

Don't be like Jack!!!

I guess, none of us would like to be like Jack. The reason is simple, all work and no play, makes Jack a dull boy. The monotony of life can be very boring. Further, being a serious workaholic can adversely affect your mental and physical health.

The current lifestyle has converted us into robots, working from 9 to 6, glaring at the screens. The stringent routine follows, and we just keep on drowning ourselves in the ocean of work and forget how many interesting things life has to offer us.

For instance, there is a cheat day for the people who regularly gym or diet. Likewise, people who are glued to their office jobs also need a cheat day, once a while. And what could be better than a day out? Turacoz Healthcare Solutions, being a medical communication company, understands the importance of fun and adventure in an individual’s life. Turacoz believes that both work and relishing are equally important in a person’s life.

So being an employee-friendly company, as we are, Turacoz planned a day-out at “Camp Wild” to start this new year with high levels of energy and fun. The team outing was full of fun and adventure. Enjoying the ride to the camp together, singing, laughing and dancing- every person was all about smiles and excitement.

There were various set-ups at the camp like rope walk, hanging bridge, etc. And different games were played after distributing the employees into 2 teams. The games played were oriented towards team-building.

Team activities help in enhancing team bonding by development of mutual understanding amongst the employees. Team work holds a great importance for any organization. Every individual is different and varies on creative aspects and work abilities and skills. It is only when you gel-up with all the differences and convert it into your strength, that you succeed.

The camp guides were very focused on team activities that help strengthen the mutual understanding and team co-ordination. The games were fun and at the same time helped employees work with each other in a different set-up, thus, helping them build a trust and understanding for each other.

Why are team outings important?
Team outings can bring some of the most unexpected results and discoveries. When restricted to the work place, an employee has various restrictions and protocols to follow and might not reveal many positive traits or skills about himself/herself. The informal environment gives them the freedom to express themselves as an individual rather than just an employee, thus generating a better chance for showcasing of various hidden aspects. Thus, importance of team outing cannot be overlooked.

Mentioned below are some of the advantages of team outings, which are out of the blue:

• Unveiling the concealed talents of employees: The participation in fun activities help team improve on the areas like communication and association. It gives the chance for the team lead to access the hidden talents of his/her team members. Many potential skills and abilities may be unleashed by being part of these activities. Like a person from finance department might solve problems and riddles quickly and then someday you might think of him for any particular problem, where his quick problem-solving skills might be of help.
• Provides employee with the much needed mental-break: As said, fun is very important in a person’s life and continuous work gives rise to various problems. A short trip can also give employees the break that they need and help improve their mental health. Always surrounded by work, employees might fall prey to stress and restlessness. This break would result in increased productivity of employees.
• Enhanced creativity and potency: Every team goes through this phase of lack of innovative ideas or find creative ways to complete tasks. Team outing helps in developing skills which can help in-office tasks. It serves as a fresh breeze for the employees.
• Inspires employees to work towards mutual goal: Employee motivation can be a challenging task and such team outings help in smoothening this task as it helps in team building and cooperation. Through various team activities, the employees learn to work in harmony to achieve mutual goals. This helps employees to perform better in a team while working towards a shared goal.
• Team connect made easy: Any team where the internal relationships of the employees are not good, cannot fair well. Team bonding is very important. A well-connected and coordinated team emerges as a strong team and it is more productive, competent and willing to work. Team outings serve as a platform where the team leaders can get in touch with their team members and get to know them and learn about their skills and capabilities and bring them together, eliminating the differences.

Turacoz Healthcare Solutions understands the importance of team building and strengthening and realizes that it is very important for an organization to give its employees some time out of office to relax. The rising levels of stress today are contributing to serious mental and physical problems. Team outings like this help employees release their stress and enjoy with the colleagues out of the workplace and develop a better bond and better communication skills.

This not only benefits employees but also the organization. Being in the healthcare domain, Turacoz understands the value of such team outings and will continue to practice this routine.

Turacoz Healthcare Solutions is a medical communication firm offering medical writing services such as publication writing, regulatory writing, pharmacovigilance support, clinical trial support, real world evidence and advisory board meetings support.

To know more about our services, write us at hello@turacoz.in

To be a part of the Turacoz family, click here.

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

Want to live a healthy life? These daily habits will help you fulfill your goal of being fit

Another year has ended marking the beginning of a new year. Lots of hopes and dreams are associated with the year 2019. We all are looking forward to this year and hoping it to bring us good luck and well-being. To achieve anything in life one needs to be healthy both physically and mentally. We all must have made various new year resolutions.
“I would go hit a gym. I would go for a walk/run. I would dump junk food. I would go on a diet.”
These are some of the resolutions many of us make every year but tend to forget them or fail to follow-up. Considering the hectic lifestyle, we lead today, it is quite difficult for many of us to go to a gym daily or break-up with junk food forever. So, does this make our plan of being fit, fail?
NO, certainly not. There are still a few things that you can do on daily basis to have a healthy and stress-free life. You might have read a lot about various diet-plans and workout routines that promise to make you shred those extra kilos and keep you fit. It is hardly plausible to tip-toe on these routines. Turacoz Healthcare Solutions understands that being fit is not only the need of the hour, but it is also extremely important for an individual to stay healthy. Turacoz also understands how difficult it is to follow a strict diet or workout plan for individuals living a hectic life.
So, now you do not need to break the sweat to be healthy. Here are some simple healthy habits/lifestyle changes if incorporated in one’s daily routine, would bring out great results:

• Early to bed, early to rise: Yes, it makes a man healthy, wealthy and wise. This nursery rhyme is not just to sing along with the kids, but it really reveals the biggest secret to live a healthy life. Getting up early in the morning keeps you healthy, fresh and does good to your body. Sleeping till late or staying awake late till might not only hampers your physical but also mental health. Try and fix your sleep time. Don't stay awake till too late and make sure to get enough sleep so that you can get up fresh in the morning.

For all the tech-savvy people, it will cost you nothing to keep your cell phones aside an hour prior to sleeping in the night. This will ensure a sound sleep.

• Get yourself to drink a glass of lemon & honey water: The first thing after getting up in the morning should be to mix lemon juice and honey in a glass of warm water and drink it. This helps boost your energy level and helps in weight reduction. Make sure to have it daily to see the positive results.
• Move it, groove it: Working out on an empty stomach is good for your body. You don’t need to go to gym for that. You can do any form of exercise that you enjoy doing. Enjoying your workout is very important. You can go for cardio workouts like running, aerobics or even brisk walk. Early morning cardio on an empty stomach helps you lose weight and perk up your energy levels by preparing your body for an all-day fat burn.
• Meditate: Your mental health is equally important. The busy life schedule has aggravated the mental issues like stress. Stress has now become a part of majority of people’s lives. Stress not only hampers your mental peace but also has adverse effects on your body. To stay stress-free and achieve mental and inner peace in your life, spare 10-15 minutes in morning to practice meditation. Do yoga and perform activities like pranayama, stretching, etc. and relax. Choose a peaceful place for this so that your senses can be calm, and you can enjoy.
• Give your taste buds some healthy fuel: Skipping breakfast can be very hazardous to your health. Make sure you eat the right breakfast. You can have oatmeal, quinoa, boiled eggs, fruit salad, milk, etc. For your breakfast. They go perfectly with your busy schedule and keep you energized for the day without adding much calories and giving your body what it requires.
• Don't sit for too long at your workplace: We are trapped in our 9-5 desk jobs and this is taking a huge toll on our health. The constant and excessive screen time and sitting hours are giving birth to various health issues. While this cannot be avoided, try to include some simple activities like stretching, walking for a while, simple exercises for eyes, etc. The main motive is to take a break from the screen and sitting.
• Drink plenty of water: Water is termed as the miraculous drink as it works wonders for your body. Make sure to drink 2-3 liters of water every day. Water keeps you hydrated, flushes out toxins from your body and helps keeping your skin glowing.
• Reduce the intake of junk food: It would be a mere fantasy to live without your favorite pizza or hamburger even while knowing what it does to your body. While there are some blessed people who won’t get fat while eating everything available on the planet, most of us struggle hard to maintain a healthy weight. The entire game is of metabolism though. Completely ditching junk is something which is recommended by almost everyone who turns out to be a health guru, but it is not possible to eliminate the intake. What you can do is reduce the intake of the junk food. Try replacing these with healthier options like dry fruits, fruits or healthy snacks like baked ones instead of fried ones. Start slowly and gradually you would be able to control your intake of processed foods.
• Have proper lunch: It might seem funny to be talking about having lunch here, but it is scary reality that many people skip lunch or have it late due to their busy schedules. Think how much your body curses you for not keeping it hungry. Ensure that you have proper and timely lunch.
• Munchy evenings: Try having something to eat as evening snack, be it dry fruits, baked snacks, green tea, etc. This will bridge the gap between your lunch and dinner time and will keep your metabolism boosted. This is a trick which many of us either don’t know or miss.
• Have a light dinner: Keep your dinner light. Make sure you don’t consume any junk or processed food for your dinner as your activity level is the lowest during this time.
• Meditating before sleep: there are many people who complain of sleeplessness or sleep apnea- a condition where you sleep but still feel tired in the morning and have a feeling of incomplete sleep. This is also a lifestyle related issue. Glaring at the mobile or laptop screens while sleeping causes the tiredness post sleep. Make sure that you keep your cell phones away an hour prior to sleep and meditate for 5-10 minutes before going to bed so that you experience sound sleep.

These simple yet effective tips will bring about a huge change in your lives and will fill your mind with positivity. They can easily gel up with your busy life and minimum efforts are required in accomplishing them. So, you can set them as your new year resolutions and set on a mission to be healthy and fit.
Turacoz Healthcare Solutions is a medical communication company that provides medical writing services such as publication writing, clinical trial support, pharmacovigilance support, regulatory writing, etc. To know more about our services, write us at hello@turacoz.in
Turacoz hopes that this new year will bring good health, happiness, fortune and wealth in your life and will help you achieve your goals and taste the success.
Wishing everyone a healthy and happy new year!