Services - SDMO
Site Management is the most important component of the entire human research. As a Site Development and Management Organization (SDMO) our aim is to provide you clinical trial sites with highest standards of Quality and with the availability of skilled; GCP trained and experienced clinicians across varied therapeutic areas. With our experience we will help you to speed up the site identification, qualification, initiation, and start up process.
All our sites are equipped with standard operating procedures which ensure ethical conduct of the trial and adherence to international and local standards of good clinical practice. We recommend only those sites which meet your study specific needs, which help to significantly reduce the time and resources in trial conduct.
We do contractual discussions in a centralized manner, which minimize the lengthy negotiations for each site.
We appoint dedicated staff like CRCs, QA Executive, Site administration manager for your study to ensure centralized and smooth communications and quality work at site.
We ensure that the site is prepared and trained to conduct the study with international standards. We place an enormous amount of responsibility for the success of your study on our CRCs and hence we ensure that they have the skills and capabilities to manage it appropriately.
Sites, which are new to clinical trials, are trained extensively on ICH-GCP, Schedule Y, ICMR guidelines and other local regulatory requirements. This enables site study team to gain a better perspective of their contribution and avoid pitfalls that new teams may get into.
All our sites are well equipped with basic infrastructure like refrigerators, freezers, centrifuge machines, fax, scanner, printer, photocopy machine, cupboards, ECG machines, computer, etc. This saves time and efforts spent on building the basic infrastructure at site.
Services for Sites
Incred CR is dedicated towards "Clinical Trial Site Development" throughout India. To achieve our aspiration, we are involved in development of quality and standard clinical trial sites through our various business models. Incred CR provides a variety of services to the Medical Institutes/Hospitals/Clinics (Clinical Trial Sites) interested to take part in Clinical Research and keen to convert their Medical Institutes/Hospitals/Clinics to a potential Clinical Research Centre.
Depending on the business needs we have developed different business models for our partners.
Protective Measures
- Establish proper Intent
- Establish the Clinical Investigator and Trial sponsor
- Establish Fare Marketing Value (FMV)
- Avoid influence of sales force in PMS process
- Limit involvement in PMS studies after study approval
- Promote transparency and disclosure
Discrepancy in Perception
- Lack of knowledge and experience in the complex and evolving area of Clinical Trial process and regulatory aspects.
- Lack of infrastructure (staff, equipments, premises and etc).
- Lack of expert support (Medical writing, biostatistics, data management).
- Time and resources constrains.
Complexities
- Limited Study Management
- Poor Documentation
- Lack of Quality Control
- Complexity increase with multicenter studies
A field report says performing PMS according to the new requirements is nearly impossible for clinicians and academic researchers without cooperation with expensively specialized experts such as project managers, statisticians, data managers, pharmacist and monitors.