FAQ from Krescent
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We are full-service preclinical and clinical Contract Research Organization, our solutions include all the activities from design, setting up and monitoring of preclinical/clinical trials and research studies, up to the management of data, statistical analysis and medical writing, covering the whole process to introduce new medical devices and pharmacy products on the market, and a Site management services covering Asia pacific region, during the study and once the marketing authorization is available.
We help our sponsors on the definition of the investigation best design, according to parameters such as a drug safety, study feasibility, best approval strategies, validity, science interest, and of course the investment profitability.
Necessary intelligence and creativity are applied on developing a global strategy which helps on saving resources to implant the medicine in the major markets possible, considering that a good global planning avoids duplicating efforts at the same time that simplifies the adaptation to the international standards to the specifics regulations of each country.
We share the knowledge of our experts on design effective programs that allows the adaptation to each country regulations and an optimal distribution of the medicinal devices and pharmacy products.
Through our investigation department and the medical team we offer our support to select the principal investigators and KOLs for each therapeutic area and warranty their commitment with the study.
We already have created links and laces with the investigators we have worked with, that let us count on with their confidence to reach the success on every investigation we take part, being them our principal prescribers.
With this investigators database we could also help the sponsor to select the best sites all over India through our site selection system and database that ensure the feasibility of the services of the site (Pharmacy, Laboratory, Image Service, General Resources and Human Resources) according to the needs of the study.
We have a wide applied experience on the intermediation process between the internal regulatory affairs department and the government agencies and competent authorities (Local, Autonomic and country) to reach the approval of the different studies and trials, simplifying the whole process and reducing the costs associated to this activity.
We work and count on with and extend net of sites and their Ethics Committees, that allows us to warranty the minimum consumption of needed resources to get the EC approval in each project we became involved.
Necessary intelligence and creativity are applied on developing a global strategy which helps on saving resources to implant the medicine in the major markets possible, considering that a good global planning avoids duplicating efforts at the same time that simplifies the adaptation to the international standards to the specifics regulations of each country.
As a key factor on the development of any trial or study, we intermediate and provide legal advice in the negotiation of the contract between the Sponsor and all the vendors participating in the study, and help you to adapt it to the local regulations.
We have a specialized team dedicated exclusively to negotiate contracts with sites, who has successfully negotiated more than Three hundred contracts, and has a great relation with the sites contract negotiation responsible.
The development and monitoring process of each study, shows different needs on it, and at Krescent Medical Research we have an enough flexible structure to adapt our procedures according to them, maintaining the quality of the whole process untouched.
Through an extended relation with several sites and investigators in India, built up during the years of experience, we know how to optimize the resources and increase the profit of the investigators efforts adjusting them to the study objectives, warranting this way the utility of each invoiced hour.
We can help on ever activity for data planning and management involved on the development of clinical trials and statistical analysis for final study report and statistic report creation:
Statistical analysis planning
Sample Determination
CRF detailed design and correction
Data Base design and development
Data Base Validation
Data Entry (Simple and double)
Queries Solving
Data codification and encryption for confidential warranty
Statistical Reporting
A huge amount of documentation is generated during each study and all local regulations requires to maintain it during several years.
We know better how to manage study documentation and we have fully equipped facilities to file during the study and to store study documentation at the end of it.
We count on with an archiving system that allows us to access to specific documentation in case of an audit or any other interest after the study.
We have a team specialized in drug registration. We offer our experience in India throughout the registration process in order to achieve your business success.
We count on with an Investigation department with a medical team responsible of selecting and supporting different principal investigators of the studies in which we participate, to warranty their commitment with the study.
Establishing collaboration links and laces with the principal investigators we have worked and shared efforts with, helps us to count on with their confidence to reach the success on every investigation we take part.
We work with several sites all over In INDIA and we have a site selection system to ensure the feasibility and to facilitate the development of the study.
We are also working to sign different agreements with various public and private investigation centres to let us get closer to the actual interest of the most relevant investigators, and combine them with the ones of different sponsors, being the link and facilitating the EC approval process with this sites.
Still have you any problem for solutions?
Head office address:
Call for help:
(843) 971-1906
Mail for information:
noreply@consultio.com
