Tuesday 21 November 2017

What is clinical trial feasibility analysis?

The clinical trial project management is the need of the hour for biotechnology companies and all pharmaceutical companies. These are head by a clinical research project manager, who comes with a complete clinical trial project management plan. The Management Of Clinical Trials is now clinical trial management system (CTMS) and there is much software available for pharma industries. However, the clinical trial management software differs with a project as they are now linked to eClinical systems. This is a web-enabled platform and anyone in the company can access a project report status, finance and generate the desired report.  



A clinical trial manager does various feasibility test for a project with the help of a team like Clinical Trial Assistants (CTA’s), Clinical Research Associates (CRA’s), Pharmacovigilance staffs and Clinical Research Coordinators (CRC’s). Managing clinical trials with a team for site feasibility assessment is the first stage in a project. He or she will give the work breakdown structures clinical trial and split them in a team.  The site feasibility in clinical trials involves with clinical trial site selection questionnaire, patient recruitment feasibility, general feasibility questionnaire, clinical research monitoring tools and by using research project management tools.

Management of clinical trials by a clinical research project manager must have good work experience. This is because; they must do as per clinical research protocol feasibility assessment forms. They do take care of clinical trial feasibility checklist and conduct clinical trial feasibility study as per the present norms of clinical research organization rules and regulations. They guide a project in such a way that it will be completed on time within the specified budget. Today, the investigational new drug (IND) is prominent in all major pharma companies and all of them need an efficient project manager to handle with the latest tools in clinical research software.

For more information visit hear : http://crimson.org.in/monitoring-clinical-trials.html

Monday 4 September 2017

Know about the roles and responsibilities of a clinical research consultants!!!

A clinical research consultant Crimson is a specialized research person, who is working with and under the direction of a principal investigator. The principal investigator is responsible for conducting overall designing and management of the clinical trial. These consultants are responsible for supporting and coordinating the activities of a regular clinical trial. A clinical trial is a process meant for evaluating the safety and effectiveness of a drug or medical device.


A research consultant works with the principal investigator, sponsor, department as well as institution to provide guidance and support on every aspect related to the study. Every project of clinical research must have one or more study coordinators depending upon the workload of the trial site. The level of the clinical trial can be divided into three stages. The three stages and the role of the consultants in these three stages are:

·         Before the start of the clinical trial

·         During the conduct of the clinical trial

·         After the finish of the clinical trial

While manufacturing of drugs, the individuals have come to know about two terms the clinical research coordinators and the cosmetic trial consultants Crimson. The manufacturing of a drug does not require any clinical trial, so the individuals are advised to hire a cosmetic trial consultant from a reliable and trusted company. The clinical research consultant makes the job of a manufacturing unit easy and helps in saving time and money.


The cosmetic trial consultants test the safety of cosmetic by manufacturing unit and provide them with the clinical research report. They work for project management and clinical trials. Most of the clinical trials are conducted in the preferred site India. There has been a great boom that has been witnessed with a growth rate of 30 percent in the Indian clinical data management industry.       

Wednesday 2 August 2017

IS the establishment of CRO’s advantageous??

There are several clinical research consultancies focusing primarily on providing highest quality service to biotechnology, pharmaceutical and devices industries for conducting research in India. The clinical trials have gained popularity, which are required for the development as well as discovery of new drugs. Also, these trials are used for finding cure for existing diseases. This has made imperative for these companies to pass their product through testing and regulatory process in a cost effective manner.


These institutions work independently to function, as an extension of the existing management structure of the clients, so as to maximize efficiency. They provide a wide range of services related to the clinical trials for the companies, in order to use the potential strength for saving cost as well as to help them in achieving quality. They assist their clients for managing and conducting the projects on clinical trials including the regulatory help.

The independentauditors for CRO in Crimson adhere to all the domestic as well as regulatory norms. Their efficiency is in providing top quality services to their clients, which stems from the fact that that have an experienced and strong advisory board. The feel proud in saying that they are with their clients during every phase of the development of drug for new drug entities as well as generic drug development.


It has been observed that the establishment of the CRO’s in India Crimson has grown at a very rapid pace. The Clinical research organizations perform a number of activities and this is done on the basis of these organizations. These institutions offer services to their clients, so as to provide feasibility of clinical projects. They undertake the quality assurance and audit of the clinical research performed by them. They also undertake training of professionals in CRO as well as BA/BE. They are most competent to handle regulatory affairs in India.

For More Information visit here: http://crimson.org.in/

Monday 3 July 2017

How are the CRO’s established???

The clinical trials and clinical research have been an essence to the paramedical field. The clinical research is all about finding ways for the patients to obtain care. The clinical research is about a million half of which is accounted for Pharma companies, CRO’s and the hospitals. The rest is accounted for Pharmacovigilance and the clinical data management. The better consultation and clinical treatment by the Pharma companies can be done with the help of Crimson Independent Auditors For The CRO.



This is considered as a better option than tradition options for approval and testing. IT is believed that the independent auditors consume less money and time for certification, approval and for the entire process of the clinical trials. When it comes to the clinical treatment, a deep analysis is made and the research is done by the CRO’s. A proper analysis is required for conducting a good research work and for the best clinical treatment. The pharmaceuticals companies have got a great help with the Crimson Establishment Of The CRO’s In India  in order to make a choice of the most clinically tested and approved drug for a medicine.

When any form of a drug or a new drug is infused into a medicine, an approval by the food and the medicine department needs to be initiated. The most common and important task performed by the independent auditors is the task of monitoring clinical trials. He is responsible for conducting site visits, site initiation, query management, establishing a communication between the researchers and the sponsors.


Also, he reviews case reports and maintains them, so as to assess the progress of the clinical trial. The demand of the medicine industry is over 50000 professional in different domains. In order  to acquire this position, an individual must have a degree/diploma/certificate related to the concerned field.

For More Information Visit Here: http://crimson.org.in/establishments-set-ups.html

Friday 28 April 2017

Choosing the Right CRO to conduct your clinical trial

Clinical research is becoming extremely valuable since the Establishment Of CRO In India. It helps in bringing new treatments that provides best treatment course for the patients. However, to achieve this, it is imperative to have right professionals to execute these trials in different part of the world.

A professional CRO or Contract research organization is not only responsible for maintaining relationship with the companies, but also provide other trial related services like management skills, budgeting and reporting are important roles of this organization. The companies can choose to outsource some necessary part of the trial to these agencies or handover them the complete responsibility of the trial. However, before hiring a professional team on your trial, there are certain aspects that need to be checked:-

·         The geographical reach of the CRO is a big factor that needs to be considered as this further helps in selection of participants to be the part of the trial. It further helps in patient participation and retention. A CRO with strong geographical reach can make a huge difference.

·         Quality of service is another aspect that should be looked into. Only a reputable and experienced organization can confirm adherence to all rules and regulations laid by the government of the country.
·         CRO should be able to provide past data of their clients for reference check. This can help in making informed decisions.

·         Should be able to communicate effectively and timely at every phase of the trial so that there are no surprises at the time of execution.

·         Their Independent Auditors For CRO should have the required skillset, interpersonal skills and decision making skills to make decisions in interest of the patient.

So, choosing the right CRO is the key to an effective research plan. 

Wednesday 5 April 2017

Choose a strong CRO for your medical study

While carrying out research and development for new medical trials in order to find a medical breakthrough and advance the medical industry, it is good to get linked with a CRO which will help in taking your project forward. Not only does the CRO provide you with guidance and technology, they also help you get medical approvals and do your marketing. They are able to manage many product development processes that are cost effective and efficient

Independent auditors for CRO carry out auditing for different medical projects that are undertaken by the CRO. The independent auditors work on freelancing basis and are assigned projects on the basis of their qualifications. They usually work from the vicinity of their homes and are on contract basis with the CRO. When they are assigned a project, they have to go the site where the clinical trials are being held and audit them in their premises. They need to audit the organization, the staff,laboratories where the trials are being held, pharmacy, new drug study, certification, training and qualification of the staff, quality of the trial, documents of the trial, and much more. Then, they prepare an audit report which states the working of the trials and whether the project is being carried ethically and report it back to the authorities at the CRO.

Establishment of CRO in India was done to keep a track of the medical studies that are being carried out in India. The CRO provides help in the form of research services which they outsource to the pharmaceutical companies and the medical industry. There are a lot of CROs which are established in India and they range from small firms to big companies.They can also be in the form of research institutions, universities, and support foundations.

For More Information Visit Here: http://crimson.org.in/


Tuesday 21 February 2017

Independent auditors for CRO handle the rise during trial run.

The establishment of CRO in India has increased off lately. This has happened due to the upcoming need and development of new drugs and medicines in the market. There are some diseases in the market that already have a couple of medicines for their treatment but it is not as successful as expected. Thus, the scientists are approached to develop a better drug for that particular disease. Here, commences the work of the independent auditors for CRO in the medicine department. The contract research organization take up the contract of the research and development of the new drug or medicine.


The CRO Company take up the responsibility of two types of risks in this treatment very efficiently, which are mentioned below.

Ensuring safety of the patients is done by CRO

The safety of the patients on whom the clinical trial is conducted is the major responsibility of the CRO Company. The CRO take up the responsibility of finding every detailed information regarding the patients on whom the test would be conducted. The establishment of CRO in India also helps in finding out about the health of the patient after the clinical treatment has been conducted on them. In case, the patient needs any kind of treatment, the CRO also provides them with it.

CRO is known for providing the financial help


The clinical treatment involves in a lot of expenditure. The CRO Company finds suitable investors and sponsors who would offer funds for the procedure of this clinical trials treatment to be executed. The expenditure of tools, machinery, new drugs, scientist, experts, doctors, and much more would be handled by the CRO Company. Thus, this would help executing this procedure in a smooth manner without any kind of tension about the money related issue for the trials to be conducted.