CIS - Compliance Implementation Services

Clinical R&D

MFG

Risk-Based Compliance

CalcPartner & ClaimsPartner

Assessment & Audit

COT & PHS Validation

PCX

Features

CIS ComplianceWatch - a compliance monitoring solution that will help you track non-compliance and disciplinary actions within your organization. Email: info@cis-partners.com for a quick demo.

Sales & Marketing Accountability.

The concept of Commercial Compliance in US manufacturing has evolved very quickly over the past several years due to increased regulatory requirements. With the US Federal Government and various State Governments becoming increasingly interested in sales, marketing and promotional activities, organizations that fail to properly implement compliance procedures and closely monitor sales and marketing activities can face substantial violations and compliance risks.

Sales and marketing compliance
CIS' experts have thorough knowledge and understanding of the FDA, DDMAC, HIPAA requirements, OIG regulations and guidelines, Industry Guidance and related state laws and regulations.

Commercial compliance Services

Description

STATE COMPLIANCE, STATE REPORTING AND AGGREGATE SPEND ASSESSMENTS AND PROGRAM IMPLEMENTATION

Code of Conduct Development, Policy and Procedure Development, System Implementation, Training and Education, Compliance Monitoring Tool, Ongoing Audits and Investigations, Data and System Integration Consulting and State-by-State reporting services.

SAMPLE ACCOUNTABILITY PROGRAMS

Policy and Procedure Development and Implementation, Training Development and Implementation, Sample Tracking and Compliance Monitoring Databases, Sales Force Automation (SFA) User Requirements, System Evaluations and System Validations for Electronic Sampling (21 CFR Part 203 and Part 11 Compliance) Program Assessments and Vendor Audits.

PROMOTIONAL ACTIVITIES

Policy and Procedure Development and Implementation, Speaker Program Development and Implementation, Promotional Activities Assessments and Audits, Vendor Audits and Internal Audit Readiness.

CONSULTANTS AND ADVISORS

Policy and Procedure Development and Implementation, Program Assessments and Audits and Vendor Audits.

VENDOR COMPLIANCE

Vendor Selection and Management: Audits, Analysis (Business Rules, SOPs) and Vetting (Evaluations, RFPs).

State compliance and reporting

CIS has State Compliance experts for assessing or auditing a current program or for implementing a State Compliance Program. Our services include Compliance Office Resourcing, Code of Conduct, Policy and Procedure Development and data gathering and reporting functions.

State Compliance program

Description

COMPLIANCE ASSESSMENT:

Compliance Roadmap
Risk Matrix
State Reporting Calendar

An objective, third party assessment, includes reviews and gap analysis of: policies and procedures, commercial activities, training programs and monitoring and auditing. Assessments include document review and interviews with various departments to ensure corporate-wide compliance. Through a Compliance Assessment, identified compliance risks are assigned a risk level and a Roadmap is provided for specific process or full program implementation. The State Reporting Calendar provides state requirements in a month to month format.

STATE REPORTING

An evaluation of data and systems to determine how to best capture, extract and aggregate, if required, reportable data.

COMPLIANCE OFFICE RESOURCING

Supplemental resourcing to assist the Compliance Officer in implementing the State Compliance Program.

CODE OF CONDUCT

Support for the development, revision and/or implementation of a Corporate Code of Conduct, essential to State Compliance.

POLICIES AND PROCEDURES

Development, revision and implementation of appropriate State and Corporate Compliance policies and procedures.

EXPENSE TRACKING EVALUATIONS AND SYSTEMS AUDITS

Evaluation and audit of existing systems across applicable departments capturing activities and reportable data to ensure regulatory compliance and data integrity. Includes vendor evaluations and RFPs.

TRAINING

Develops and implements Compliance Training Programs and accompanying documentation.

MONITORING AND AUDITING

Process implementation and tools to address the need for ongoing compliance monitoring and auditing on an individual, departmental and corporate level and the implementation of appropriate corrective and disciplinary actions. Ongoing auditing and monitoring ensure programs evolve with changing regulations.

VENDOR ASSESSMENTS/AUDITS

Assessments/Audits of vendor managed programs for alignment with Corporate Policies and Procedures, business rules and State requirements.

CIS offers a compliance monitoring solution, called CIS ComplianceWatch that will help you track non-compliance and disciplinary actions within your organization. This easy-to-use database allows you to capture non-compliant activities by individuals and the disciplinary action attached to an incident. This allows the escalation of disciplinary action and ensures a consistency in disciplinary actions for certain activities. The database offers reporting options that will help you evaluate the entire Compliance Program, based on the frequency of certain incidents, or evaluate compliance on an individual, district or company-wide basis.

Compliance services

Features

Sales & Marketing Accountability.