GENECHT RESEARCH
Genecht Research Pvt. Ltd. is an emerging Contract Research Organization aiming to provide fierce support for BA/BE and clinical trial studies of pharmaceutical, biotechnology and cosmetic industries across the globe.
Genecht Research Pvt. Ltd. ensures that all the studies performed are in compliance with ICH-GCP, GLP, GDP and applicable regulatory guidelines. We have established our policies that follows work ethics and we believe in accelerating success adhering to our principles, organically.
Genecht Research Pvt. Ltd. aims to provide high level of technical competence and customer service without compromising on quality, with strict adherence to the timelines and maintaining confidentiality.
Benefits of Partnering with Us
Benefits of Partnering with Us
BENEFITS
- Use of electronic Case Record Form (eCRF) to facilitate online data entry
- Use of QR code on vacutainers and RIA vials to avoid possible errors due to sample mix-up/ interchange
- Ensure quality conduct of study by adhering to the study protocol and inhouse SOPs. Facilitate continuous monitoring during the study off site through CCTV access
- Provide a broad range of skills, offering a complete spectrum of services covering all the needed elements to make your clinical research work successful
- Perform studies with a variety of subjects, population including healthy male/female, postmenopausal women, geriatric, pediatric, hypogonadal male and smokers
- Clinical and bioanalytical units are under one roof and easily accessible to volunteers and sponsor's/monitor's
PROJECT MANAGEMENT DEPARTMENT
- Project managers delivering all projects through superb co-ordination and with continuous communication with sponsor. Genecht has a highly-competent project management team who manage complex projects with great fineness and accuracy.
- Oversee the entire project flow from the first client Interaction through to the final report
- Offer post-submission query resolution to support product approval from the Regulatory authorities
- Providing client-specific project managers, increasing the ease of communication
- Genecht offer project management services to the clients who wish to have a world-class, scientific project manager supporting their projects.
MEDICAL WRITING DEPARTMENT
Our Medical Writers:
- Prepare the study protocols and reports in line with the sponsor’s requirements and applicable regulatory guidance
- Co-ordinates with the ethics committee for the necessary approvals
- Provides full compliance with applicable regulatory requirements
REGULATORY DEPARTMENT
Our Regulatory Team:
- Recommend to the sponsor whether to apply for BE NOC/T-License on need bases
- Apply for BE NOC/T-License in order to have approval for execution of BABE/ Clinical trial studies
- Review and complete required documentation for the applications to local regulatory bodies to ensure appropriate study-related approvals are in place on time
- Track the progress of all relevant DCGI/CDSCO approvals in coordination with the project management team
- Work with the project management team keeping them updated about the authorizations to ensure that all the required DCGI/CDSCO approvals are in place
- Set meetings with DCGI officials for any query resolution
SCREENING DEPARTMENT
- Genecht has dedicated team at Mumbai location responsible for ensuring that the sufficient number of volunteers meet the requirements of each protocol.
Our Screening Department:
- Recruit from a voluneers database across India that includes healthy adult male /female, postmenopausal female, elderly male etc.
- Utilize Online Volunteers Information System (OVIS), a comprehensive database to avoid cross participation amongs CROs
QUALITY ASSURANCE
Our Quality Department oversees
- Protocol
- Standard operating Procedures
- Regulatory Guidance
- Regulatory Query
- Sponsor Query
- Support Investigational site during Inspection
- Routine Review of SOPs
- Compliance of various Processes
- Quality Review System
- Investigational Site Audit
- In-process Audit
- Retrospective Audit
- System Audit