GRC provides full project management service from Phase I to phase IV clinical trials.
GRC assigns a dedicated Clinical Project Manager (CPM) to communicate and manage all study related activities and act as the primary liaison to the Sponsor and the site team
Site selection is a critical component of a clinical trial success. The ultimate selection of sites becomes a collaborative effort between GRC and its client.
Site Selection Services include:
- Site Identification, Recruitment and Retention
- Feasibility Assessments
- Identification and selection of investigators
- Identify Geography of Patient Populations
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GRC, medical monitors work closely with the Sponsor and each internal project team throughout the course of a study and/or a product’s phase of development.
Our medical monitoring services bridge all phases of clinical research and development.
- Identification and management of IEC/IRB
- Regulatory document review and collection
- Review of study documents, source data verification, CRFs and Informed Consent.
- Site contract, budget negotiation, and grant administration
- On-site training
- Site qualification, initiation, and closeout
- Interim site monitoring
- Handling protocol deviations
- Drug accountability and Reconciliation.
- Site Closure (Close-out visits).
GRC provides conscientious care at every stage of data management, insuring reliable and verifiable data points. With comprehensive experience in managing clinical trial data, our personalized, performance-driven approach ensures our clients receive clean data on time.
Study documentation is developed to document all steps of the data management process and study specific procedures that include Data Management Plan (DMP), Data Validation Plan (DVP) including the validation checks specifications, study specific guidelines for SAE reconciliation, and medical data coding.
Data Management Services includes:
- Design/Development of Case Report Form.
- Case Report Form (CRF) Annotation.
- Development of the Data Management Plan (DMP) and Data Handling.
- Database Design (EDC Platform), Development and User Acceptance Testing.
- Development of the Data Validation Plan (DVP) including the Data Validation Checks Specifications, Programming and Testing.
- Double Data Entry, Automated Double Data Comparison and Synchronization.
- Electronic and Manual Discrepancy Identification and Automated Data Queries (ADQ) Generation.
- AE/SAE Reconciliation and Reporting.
- Identification and Tracking of Protocol Violators.
- In-stream Patient Closure and Quality Control Auditing.
- Database Lock.
- Final Archiving and Imaging.
GRC has an extensive experience to develop a statistically rigorous and customized plan for each project.
Our statistical programmers are current with the latest programming techniques and features of the SAS system, among other statistical software packages.
- Consultation on study design, sample-size estimation, and Statistical Analysis Planning (SAP)
- Study randomization
- Analysis programming
- Interim / sequential analysis
- Integrated summaries of safety and effectiveness
- Expert data analysis
- Data browse/Query (Integrated Review™)
- Statistical Analysis Reports (SAR)
Medical writing is an established core function at GRC. The medical writing team is fully integrated with the Medical Monitoring, Pharmacovigilance, and Biostatistics teams.
The input of our Veteran Clinical Researchers, Biostatisticians, and Bench Scientists ensures that our client’s key messages are medically and scientifically sound and acceptable to the clinician and researcher alike.
The group skillfully handles writing projects related to drugs, biologics, and medical devices. Our writers have experience with complex medical research topics such as proteomics, epidemiology, and pharmacogenomics. GRC has established procedures for document management and a broad collective experience in current electronic submission formats and standards. Our documents undergo rigorous quality assurance review before delivery to our clients.
Our Medical Writing services:
- Literature reviews
- Abstracts / Presentation
- Protocol Writing
- Informed Consent Form development
- Investigator Brochure (IB) development
- Leaflets, Case Reports
- Clinical Study Reports
- Advisory Board support
GRC has an expanded network of dedicated, qualified medical colleagues who support the clients’ requests on a timely basis.
Medical Affairs Services:
- Conference and Symposia
- Key Opinion Leaders (KOL) Management
- Medical training
- Promotional materials development
- Continuing Medical Education (CME)
- Patient Educational programs.
GRC has partnerships with wide range of international experienced trainers who provide accredited certifications for attending trainings led by GRC.
- Soft Skills
- ICH-GCP Workshops
- Biostatistics for Non-Biostatisticians
- Project Management
- Health Economics
Consulting on National / International Regulatory requirements
Regulatory liaison for clinical trial permission along with preparation, submission for the required regulatory documents and follow-up till approval
Safety reporting in the prescribed / technical format to regulatory authorities
Import license of the Investigational Medicinal Product (IMP) issuance before the clinical trial conduction
Export license of the biological samples’ issuance before the clinical trial conduction
Common Technical Dossiers (CTD, eCTD) preparation