Services

1. Site Identification: 

   We help sponsors and investigators identify suitable research sites with the necessary infrastructure, expertise, and patient populations.

2. Feasibility Assessment: 

   Our team conducts thorough feasibility studies by collecting information and/or data to ensure that the selected sites meet the study requirements and have access to the right patient demographics.

3. Site Selection: 

   After thorough assessment of the information collected during the feasibility assessment, our team with expert guidance and consultation with the operations and leadership team officially selects the sites. After this step, submission to ethical committees and contracting process can begin.

1. Regulatory Support: 

   We assist in the preparation and submission of regulatory documents, ensuring compliance with local and international regulations.

2. Contract Negotiations: 

   Prime Services helps in negotiating contracts and budgets between sponsors and sites, expediting the initiation process.

1. Site Coordination:

   Our experienced project managers oversee site activities, ensuring that the trial is conducted efficiently and within protocol.

2. Patient Enrollment: 

   We implement strategies for patient recruitment, using our extensive network to identify eligible participants and ensure that the patient recruitment is completed as projected in the recruitment plan.

3. Site Training: 

   SMO-CR offers training to site staff, ensuring they are well-equipped to conduct the study effectively. We also ensure that the site staff is equipped with the updated CV and Good Clinical Practice (GCP) and make sure that it is collected as per the guidelines.

1. Data Collection: 

   We ensure accurate and timely data collection through standardized processes and technology.

2. Data Entry and Validation: 

   Our experts handle data entry and validation, ensuring high-quality data for analysis.

3. Protocol Deviations: 

   We closely monitor the data entry to ensure that there is minimum number of protocol deviations and coordinate with the site team to mitigate those deviations in the future.

1. Quality Oversight:

   We maintain rigorous quality assurance standards, monitoring site performance and ensuring adherence to Good Clinical Practice (GCP).

2. Regulatory Compliance: 

   Our team keeps sites up to date with regulatory changes, ensuring that the trial remains in compliance.

1. Recruitment Strategies: 

   We design and implement patient recruitment strategies that engage and enroll eligible participants effectively. We plan and organize investigators meetings with site team and investigators to motivate them for patient recruitment and address issues if any.

2. Patient Retention Programs: 

   SMO-CR develops retention programs to keep study participants engaged and committed throughout the study.

1. Monitoring Visits: 

   We conduct regular monitoring visits to assess site performance, data accuracy, discuss any issues at site and protocol compliance.

2. Auditing Services: 

   SMO-CR offers auditing services to maintain data integrity and compliance with industry standards.

1. Study Closeout: 

   We help sites complete the necessary activities for study closeout, ensuring timely and efficient trial closure.

2. Data Analysis and Reporting:

   SMO-CR assists in data analysis, report generation, and dissemination of results.

Why Choose Our Archival Services?

• Regulatory Compliance: We ensure that all documents are archived in accordance with regulatory requirements, including ICH-GCP guidelines and local regulatory authorities.
• Security: Our state-of-the-art archival facilities guarantee the highest levels of security, with controlled access and advanced protection against unauthorized access and environmental hazards.
• Accessibility: We provide efficient retrieval systems, ensuring that documents can be accessed quickly when needed, facilitating audits, inspections, and reviews.
• Longevity: Our archival solutions are designed for long-term storage, preserving the integrity and readability of documents for the entire duration of the required retention period.

Study Documents

• Protocols
• Informed consent forms
• Case report forms (CRFs)
• Study reports
• Regulatory submissions

Site Documents

• Site initiation visit reports
• Monitoring visit reports
• Close-out visit reports
• Site logs
• Communication records

Ethics Committee Documents

• Ethics committee approvals
• Correspondence with ethics committees
• Continuing review documents
• Adverse event reports

Sponsor Documents

• Contractual agreements
• Financial documents
• Correspondence and communications
• Monitoring plans

Investigator Documents

• Investigator brochures
• Curriculum vitae (CVs)
• Training records
• Delegation logs
• Adverse event reports

1. Collection: We collaborate closely with study sites, sponsors, and investigators to gather all necessary documents for archival.
2. Organization: Documents are systematically categorized and indexed for easy retrieval.
3. Digital Archiving: In addition to physical storage, we offer digital archiving solutions that include secure, cloud-based storage with encrypted access.
4. Retention Management: We manage the retention periods for all documents, ensuring compliance with regulatory timelines and guidelines.
5. Destruction: At the end of the retention period, we provide secure destruction services, ensuring confidentiality and compliance with regulatory requirements.

Prime Services CRO is committed to maintaining the highest standards of document management, ensuring the integrity and confidentiality of your clinical research data.