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.