In the beginning, contract research organizations (CROs) were able to assist medical device companies by providing the testing of their products and validated. Today, CRO for nutraceuticals provide many different options, so it is important to examine your research requirements thoroughly prior to beginning searching for your perfect CRO.
The International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) defines an organization for contract research as:
“A individual or an organization (commercial academic, academic, or any other) hired with the sponsor carry out any or all of the test-related duty and function of a sponsor:
A sponsor can transfer some or all of its duties and functions related to trial to a CRO. However, the ultimate responsibility for quality and integrity of trial data remains at the discretion of the company sponsor. CROs should establish the quality and assurance procedures as well as quality controls.
Any duty or function related to trials that is assigned to and taken over by a CRO must be outlined in writing.
All duties and tasks related to trials that are not explicitly transferred to and the CRO, remain with the sponsor.
Any references to sponsors in this guideline are also applicable to a CRO in the extent that the CRO has been able to perform the trials-related tasks and duties of the role of a sponsor.”
No matter if you utilize CROs and not, as the person who sponsors your study are accountable for the ethical design of your study in accordance with the laws and regulations and the accuracy and reliability of the data as well as its interpretation.
Strategic Planning & Execution
CROs can offer you the knowledge and expertise required to conduct research , but you must first know what you want and need from a CRO. Here’s a 10,000-foot overview of the steps required to create and conduct the research study:
1.) Decide on the question you intend to solve. While it might seem easy the research question will guide the entire research process. It should clearly define the question that requires a response. Although it may sound simple however, it needs careful thought regarding a variety of issues like:
What is the most current information available?
What’s the gap between what is available and what is required to know in order to answer your question?
Is your question too broad or narrow enough to gather the information you require?
It is it possible to investigate your issue? (Is it ethical? Do methods exist? etc.)
2.) Select the most efficient method of conducting your study. Choose a suitable study design and then write a research plan. The research protocol clearly spells out the procedure for conducting the research to the extent that researchers are able to follow to gather the necessary data.
Research protocols typically contain:
- An introduction that provides the motivation behind the study
- The study’s hypothesis and question
- The study’s design
- The statistical methods used in analysis
- Data collection methods & instruments
Description of the population studied and subject selection criteria
3.) Conduct the study and gather the results.
4.) Examine the data and evaluate the results.
5) Write down the results.
The everyday requirements for managing a study take place in the background. They involve the creation of instruments for data collection as well as data collection as well as data entry monitoring of data quality and much more. CROs could hire clinical researchers to communicate with research sites as well as data collectors, data monitors technicians, statisticians, researchers and other professionals to complete the various tasks associated with the research study.
Finding The Right CRO
CRO for nutraceuticals may be large or small and generally provide the “menu” range of offerings. After reviewing your research requirements and requirements, you’ll have to choose and “qualify” CROs.
In the ideal scenario, you’ll need to visit the CRO’s facilities and talk to staff members, scientists, management as well as clinical and data services, as well as quality assurance. It is possible to use these criteria as a basis for evaluating the potential CRO however, it is important to modify them to fit your individual requirements.
Guidelines and Policies: Conduct an exhaustive review of the organization’s arrangement, the status of accreditation as well as compliance with the legal and regulatory mandates regarding clinical research.
Human Resources Management (PM): Read or debate the expertise and experience of CRO staff as well as staffing amounts, descriptions of jobs, and training reports.
Facilities: Check the equipment and structures used to house animals, or for visits to clinics to ensure stability, quality and conformity.
Security: Confidentiality of the CRO is crucial. Examine the security measures for information and correspondence, as well as to ensure confidentiality of employees.
Crisis Management: Go over the plan for managing crises to ensure it is covered by every possible scenario and provides that you are in constant contact with the person who is sponsoring.
Other criteria to be considered
Apart from these additional criteria, aside from these, there exist “softer” factors that require consideration. The researcher’s Glass and Beaudry identified five factors that CROs’ users consider important in the selection process for CROs (see Table 1).
1.) The first thing they refer to as team the first time they called team chemistry. A good relationship between a sponsor and CRO is more likely when both parties share similar values, ethics of work and general principles. If you are unsure about something following a meeting with a CRO, you should go to your gut.
2.) The second criterion is the satisfaction that the CRO team managing the project is completely committed to the undertaking. If you sense that your project isn’t going to get the attention it deserves and attention, you should consider resigning.
3) The majority of employers, when interviewing candidates for employment are looking for experience. This is the same when looking for a CRO to fulfill your requirements.
5) The last criterion is more obscure. The background of team members is an amalgamation of experience as well as experience, and also charisma. This is the best time to evaluate your feelings about working in the team by examining the personal relationships between team members as well as between the team and sponsors.
You must ensure that you are putting your best to the table when you design and conduct a clinical trial. Consider the above-mentioned questions together, and identify your strengths and weak points.
A well run Late Phase Clinical Trials is an investment of time and money and is frequently crucial to the success of a nutraceutical product.