●END-TO-END TRIAL MANAGEMENT

●MEDICAL WRITING

●MONITORING

●AUDITING

●CR-TRAINING

●CR-CONSULTING

END-TO-END TRIAL MANAGEMENT

RKM-CR has a team of passionate, experienced and dedicated clinical research professionals offering end-to-end Trial Management. Whatever be your clinical trial requirement, RKM-CR is your trusted partner in accomplishing all of the below mentioned activities:

• Site Management (Selection, Feasibility, Activation, Study-Initiation, Screening-Enrolment-Follow-up, Study Closure)

• Coordinating Regulatory Affairs

• Coordination with the Ethics Committees

• Training Site Staff (PI, Co-I, Sub-I, CRCs, Nurses and Phlebotomists)

• ISF Management (Populating all essential documents as required as per ICH-GCP_R2)

• IP Management (Receipt, Accountability, Return / Destruction)

• Archival Support

MEDICAL WRITING

RKM-CR has a combination team of medical doctors, PhDs and Scientists who are trained experts at Medical Writing. For all your medical writing needs including but not limited to the following – get in touch with RKM-CR:

• Site Management (Selection, Feasibility, Activation, Study-Initiation, Screening-Enrolment-Follow-up, Study Closure)

• Coordinating Regulatory Affairs

• Coordination with the Ethics Committees

• Training Site Staff (PI, Co-I, Sub-I, CRCs, Nurses and Phlebotomists)

• ISF Management (Populating all essential documents as required as per ICH-GCP_R2)

• IP Management (Receipt, Accountability, Return / Destruction)

• Archival Support

MONITORING

RKM-CR comprises of excellent and seasoned monitors who have handled DCGI audits, FDA-audits and multiple audits from other independent auditors. Our CRAs are some of the best in the business and are well-versed in both onsite and off-site monitoring. RKM-CR also undertakes monitoring as a stand-alone service as well. We take care that the following procedures are conducted as per the approved Protocol, local regulatory guidelines and ICH-GCP_R2:

• PMP Preparation

• Site Selection and Feasibility Visits

• Site Start-up Visits

• SIVs

• Routine MVs

• SCVs

• Archival / IP Destruction at Site Visit

AUDITING

RKM-CR also offers specialized auditing services. We also undertake peer review – certification audits wherein our auditors visit the host CR Company and perform a complete review of their SOPs, QMS and Overall Staff Qualification to ensure they meet global industry standards of quality and expertise. RKM-CR also undertakes stand-alone auditing for all clinical trials. Following are our auditing services:

• Routine Site Audit

• For-cause Audit

• Sponsor’s Independent Audit

• Quality Check Audit

• Certification Audit

• Site Preparation Audits

CR-TRAINING

RKM-CR offers best-in-the-industry training for student-aspirants aiming to enter the lucrative Clinical Research Industry. Whether you are a medical doctor, BDS, BAMS, Pharmacist (D.Pharm, M.Pharm, etc), Life-Science Graduate (MSc/BSc in Botany-Zoology-Microbiology-Biochemistry-Biotechnology-Health Sciences) or a Nursing graduate seeking professional training services with certification and placement assistance – get in touch with us now. Following are the training services offered by RKM-CR:

• 3-Month Certification Course with Placement Assistance

• GCP Certificate and Training for CRAs / CRCs

• CR-Symposiums at Colleges for Industry awareness and Career outlook

• GCP Certification and Training for Ethics Committee Members

• GCP Certification and Training for Investigators and his/her site staff

CR-CONSULTING

RKM-CR is adept at consulting services. Are you a new-product Sponsor looking for guidance into testing your product? RKM-CR is your able partner in ensuring your product hits the market at the specified timeline whilst being in-line with the Indian Regulations. Are you an independent CR services provider or vendor looking for collaboration? Get in touch with us for a mutually benefitting relationship. Following are the consulting services offered and the list keeps increasing as we seek out more opportunities:

• Sponsor-Consultations on Trial Conduct (Management-Approvals-Timelines)

• Peer CRO/SMO Consultations on Marketing Strategies and Staffing Solutions

• Investigator Consultations on handling Monitoring Visits, Audits and Inspections

• SOPs drafting for CROs / SMOs and wannabe ECs

• General CR Consulting for students and professionals