An international, full-service CRO that specializes in conducting and managing clinical trials.

Transcription

1 An international, full-service CRO that specializes in conducting and managing clinical trials. In Operation Since Approved Products Zero 483s Clinical Operations and Monitoring Risk Based Monitoring Patient Reported Outcomes, epro Clinical Call Center-Screening, Recruitment and Safety Data Management and EDC IWRS Trial Masterfile CTMS Management Medical Monitoring / Safety Management Trial Rescue Grants, Contracts and Site Payment Quality Assurance Regulatory Compliance Global Strategic Sourcing Medical Writing Biostatistics Pharmacovigilance NCGS, Incorporated 65 Society Street, Charleston, SC (843) www.

2 NCGS, Incorporated is an international full-service CRO, providing clinical development support to Pharmaceutical, Biotechnology, Medical Device and Diagnostic companies. NCGS business model is discernibly different than industry standard: Utilizing highly tenured staff, NCGS consistently delivers studies on time, within budget and of the highest quality. NCGS is a WBENC certified Diversity Supplier, has been in operation for 30 years and supported the approvals or expanded labeling of 31 products with zero 483s. NCGS understands that the CRO-Sponsor relationship is one of shared vision, complementary expertise and trust. NCGS team understands the demands of the life science industries, seeking ways to make each clinical effort more quality based, thorough, timely and cost-effective. NCGS mission is to protect research subjects, capture quality data and maintain the integrity of science with the same passion one would protect their own domain. Each staff member is charged to function under the mantra, This product could easily be used on your parent, sibling, or yourself. It is not only our hope for this product, it is the world s hope for this product. NCGS Quality Performance and Discernible Difference: In operation since 1984, 30 years 31 approved products Zero FDA 483s CRA Average Experience - greater than 10 years Turnover Rate- 3% Diversity Supplier- Women Business Enterprise National Certification Several former clients are currently NCGS staff Service Offerings Clinical Operations and Clinical Monitoring Clinical Call Center Screening, Recruitment and Safety Data Management, EDC IWRS Fully integrated to EDC Platform (eliminating duplicate license fees) etmf and CTMS Management Medical Monitoring and Safety Management Grants, Contacts, Site and Vendor Payment Regulatory Compliance and Quality Assurance Global Strategic Sourcing Medical Writing Biostatistics Phamacovigilance Ex-US Regulatory Affairs Trial Rescue NCGS Overview Global Footprint US, Canada, and EU (Latin America, Asia- Pacific including India through collaborations)

3 Clinical Operations and Monitoring NCGS has a proven quality track record with 31 years of clinical operational excellence with zero 483s. Sponsor challenges and pain points are addressed with First in Class research professionals. Many NCGS field and management professionals were previous NCGS clients. Several staff held site management positions early in their careers, providing them with insight into creative site management for a productive study outcome. Clinical Operations Staff Experience Greater than 10 years tenure on average Cross-functional expertise Monitoring and Project Management Regulatory Due Diligence and GCP/ICH Compliance Auditing Strong Clinical Data Management Interface 65% have Director and Global Director Experience Available under FSP or Full Service Employ Clinical CAPA (Corrective and Preventative Action) In-Process Functional Flexibility Back-Up- Each assigned position has an assigned back-up Back-up strategy is employed from study onset, not implemented emergently Absence of attrition and solid clinical development knowledge Key elements to ensure site performance and relationship success. Functional and Interactive consistency is achieved employing strategic back-up model - Cross team and site communications highly effective with tenured staff Continuity breeds quality results and site satisfaction Consistently delivering studies on time, on budget and with the highest quality Superior results with an elite development team that functions strategically 24/7/365 call center ensures ready access for clinical, regulatory and safety inquiries Communication Through Diverse Methods: Avoid Sea of Sameness Relationship strength is communication based beyond weekly CRA Contacts Medical Monitor monthly rotations and monthly call notations Sponsor Updates: Metrics, early obstacle identification, intervention successes Site Contingency Plans: Define / Employ / Mitigate Risk Investigator Teleconferences Newsletters, FAQs, Blasts

4 Clinical Operations and Monitoring Strategic Subject Recruitment Therapeutic Drivers Referral(s): Physicians, hospital units, clinics, free clinics, urgent care clinics Media / Internet: Clinical Trial Website, Therapeutic Website, Site Website Secure Sponsor/NCGS Web Portal Create self-referral opportunities Poster, fliers, ads, support groups ipad and iphone free aps Social Media: future (Twitter Guidance) Subject Retention Plan > Outline > Remind > Modify > Caregiver considerations Electronic and manual recall tools Direct Subject Alerts HIPAA Compliant Electronic reminder via phone or internet Evaluability Train and re-train Compliance management Query discussion and teaching tool Avoid repeat errors Grant payments > fiscal impact deviations > motivation escalates performance Open Payment Act Compliance Quality Based Management Standards Quality Plan / Project Management Plan Assumptions and Deliverables Metric Based Patterns of Errors Early Detection Continuous Improvement Clinical CAPA (Corrective and Preventive Actions) In-Process Timelines, Milestones, Resource Allocation Tools, Report Formats Risk Mitigation Plan Performance Assessments Obstacle Identification Root Cause Analysis Intervention Success Communication Plan and Issue Escalation Senior Management Oversight

5 Clinical Operations and Monitoring Risk Based Monitoring Trends in Remote Monitoring and/or Risk Based Monitoring Quality enterprise GCP/ICH E6/FDA compliant remote monitoring practices Subject Safety Enhanced Immediate review Data Quality and Integrity Improved Data patterns emerge Critical Parameters I/E; ICF; Endpoints; safety/sae; D/C reason; extra tests; adjudication; blinding; accountability Source Upload de-identified critical source data Monitoring Plan Identify methods, rationale and detail of processes On Site Monitoring Critical at study onset; sites at risk; study complexity driver, data outliers Deviation tracking Root cause analysis Remote Monitoring Documentation Activity date; summary of data reviewed; noncompliance; action plan Fiscally responsible with quality outcome Patient Reported Outcomes Listen to the Patient Communicate the patient perspective Strategic study design details Value messages specific to patient population Measures strategically support product approval/labeling, reimbursement Validated tools adaptable, reliable (minimal user-user variability) Compliance mapping indicators Establish clinically meaningful change Strategic post-marketing product value Subject Retention Plan > Outline > Remind > Modify > Caregiver Considerations Electronic and Manual Recall Tools Direct Subject Alerts HIPAA Compliant

6 Data Management, EDC and IWRS NCGS provides sponsors with quality data management services. EDC, IWRS and CTMS systems are fully integrated. All systems are fully validated, 21 CFR part 11 compliant electronic data capture solutions that are capable of handling small, single site Phase I trials up to multi-national, multi-lingual Phase III and IV trials. Data Management Plan Development EDC Solution: eclinical OS Web-based solution with scalability Accessible through any web-enabled device including mobile platforms Fully integrated EDC, IWRS and CTMS solution Adjudication module Clinical image management External data uploads and verification Missing results reports Edit specifications - CDISC standards Coding - Adverse Events (MedDRA) and Medications (WHO Drug) SAE Reconciliation Source data uploads Risk based monitoring capable Compelling pricing structure User fees based on sites and trial duration, not annual fees Database Closure/Lock Rapid subject cleaning and datalock 5 days last monitoring visit Legacy Experience Other EDC and Data Management Systems Inform, MediData, Oracle RDC, ClinTrial IWRS Randomization Fully incorporated into EDC user s flow One time fee at study initiation No ongoing duplicate user fees Automatic database validations to ensure patient eligibility Auto-population of randomization information onto ecrfs for data review Drug Supply Bulk v. unique drug supply Inventory management Expiration management Custom reports Automatic notifications

7 etmf and CTMS Management NCGS will establish and maintain your trial master file in audit ready compliance with our robust and expanding TMF/eTMF centralized team of more than 100 experienced regulatory document specialists and regulatory associates. NCGS e-tmf preferred solution meets global regulatory compliance requirements (GCP, ICH E6, FDA, 21 CFR Part11 / EU Annex 11 compliant, EMEA, etc.) and follows the hierarchy and indexing standards from DIA s TMF Reference Model (Version 2.0, June 2012) which is an extension of the EDM Reference Model addressing standards for electronic submissions. NCGS has proven talent regarding audit readiness as evidenced during our most recent FDA audit 27FEB-1MAR 2012 for an international infectious disease trial resulting in zero findings. TMF/eTMF Sponsor Drivers - Establishing or Merging TMFs/eTMF: Launch of a new compound Acquisition of a company or compound and need to merge critical TMF documents Joint development effort Acquisition of a new etmf system requiring resources for consolidation efforts TMF centralization efforts requiring a preferred TMF or etmf vendor Access, Security and Achieving Compliance: Web-based secure centralized access to CRO and stakeholders Decreases regulatory start-up time and review processes Eliminates duplication of resources and multiple back-up paper repositories Improves ongoing document reconciliation Provides document capacity to meet global trial management needs Regulatory compliance CFR Part 11 compliance (limited access, password protected, audit trails, date and time stamps) Accuracy, completeness and legibility Certified - employing a validated QC process Records are enduring and available when required Provides standard reports - missing and incomplete documents with visual indicators Provides a competitive advantage to stakeholders in providing evidence of GCP and of the trial s overall scientific credibility Risk Mitigation Noncompliance Demonstrate compliance of the investigator, sponsor and monitor with the standards of good clinical practice (GCP) with all applicable global regulatory requirements Standardizes processes for ensuring document compliance Predefines list of expected documents for every trial based on specific study characteristics Decreases complexity of maintaining required FDA regulatory documents by streamlining the creation, collection, management and storage of critical clinical research documentation Image and indexing quality checks Reports against client-defined milestones; expected versus actual Clarifies picture of incomplete or overdue documents

8 etmf and CTMS Management Benefits: Rapid start-up Wizards - Simplify design processes (quick and repeatable) No additional capital equipment outlay or investment by sponsor Native MS Office and Adobe PDF support Rapid QA process Unique trial-based or compound-based user licensing model -like interface Metrics Planned versus actual milestones Decreases audit preparation time Customizable reports, views and document sub-type Reduces expensive redundant storage requirements Eliminates paper handling, paper storage and fire and security expense Managers no longer need to produce off-line tracking spreadsheets Configurable detailed reports by site, study, compound Case Study: NCGS is currently merging worldwide documents for 200 ongoing trials for one of the largest Pharma companies in the industry. Merging historical documents into one central system in the presence of ongoing trials from fifteen (15) different repositories and alternate system types is a complex operation. NCGS Discernible Difference and Competitive Advantage: Robust regulatory compliance staff with years of previous experience in essential document processing during trial launch Staff is fully versed in document quality control standards, document conversion, critical adherence to specified naming conventions and electronic transfer from multiple formats or environments NCGS can manage your etmf in our etmf electronic preferred platform or your preferred platform NCGS can provide this level of expertise at costs substantially less than our global competitors NCGS etmf preferred solution provide stakeholders evidence of GCP compliance and a clinical trial s overall scientific credibility

9 Medical Monitoring / Safety Management NCGS medical monitors have medical practice and clinical research experience which leads to an understanding of site challenges and resolution recommendations. Therapeutic expertise is provided by board certified in-house physicians in key therapeutic areas. Medical monitors are familiar with key opinion leaders (KOL) and high-enrolling sites. They drive physician to physician communication with 24/7/365 coverage. Medical Monitoring and Compound Development Services Compound development plan Statistical analysis plan review Clinical data capture plan review Investigator site selection input Protocol training / PI meeting Call center site support 24/7/365 and language translation services Interaction with regulatory agency Protocol development Safety Management Services Eligibility and safety assessments Safety management plan Data safety monitoring board Safety data capture plan Data Safety Charter Protocol safety section Reconcile safety and clinical databases Distribution of expedited reports to PI/IRBs Safety Reporting Services Clinical study reports Abstracts and manuscripts SAE report review Safety narratives Safety legacy database integration Coding MedDRA (or sponsor) Data safety listings and reports Annual reports

10 Grants, Contacts and Site Payments Rapid Study Start-Up Rapid contract execution from site qualification visit NCGS contract processes employ efficiency in language and budget negotiation Standard acceptable changes identified at study initiation and updated as language negotiations are accomplished Discovery of any obstacles to contract full execution at individual sites Discovery of any site contract language mandates that may assist sponsor legal prior to receipt of contract comments (i.e., indemnification agreements, third party agreements, investigator fraud clauses, etc.) Alerts for revisions driven by enrollment feasibility questionnaire information that may provide insight into site processes and mandates Timeline, order and impact of contract verses IRB approvals researched to determine if site can meet study initiation target dates Payments tied to Evaluability Metrics Quality driven payment structure Feedback to the site is provided for each subject payment and incremental decrease of full payment is employed for evaluations the site fails to perform Feedback and payment reductions lead to site realization (cause and fiscal effect) of sub-quality performance impact NCGS payment method eliminates improper incentives for non-performance which is a growing agency concern Fiscal accountability shifted to the site for study related procedures drives study compliance metrics and evaluability Evaluability Shifts In previous trials where NCGS has rescued the study - grant savings of $250,000 have been realized due to improved evaluability Quality performance of NCGS initiated trials avoids needless lost grant fees due to focused subject management and close fiscal review of payments NCGS payment process offers sites efficient and expeditious payment turnaround CRF in-house and reviewed clinically and for payment within 24 hours Eliminates duplication of effort between clinical and contract payment group Reasonable fund retains are held until query resolution accomplished Open Payment Compliance Site Satisfaction Payment efficiencies lead to investigator and site satisfaction

11 Quality Assurance & Regulatory Compliance NCGS recognizes the importance of quality initiatives in all aspects of research. The Quality Management Plan is the cornerstone of all development efforts ensuring regulatory compliance and quality deliverables. Quality Management Plan / CAPA (Corrective and Preventative Actions) Development of standards of operations to achieve a quality-based system Applicable regulations addressed Identify quality and efficiency objectives Clear delegation of responsibilities Root cause analysis Implementation of quality-based standards of operations Resource allocation and training Define metrics to measure efficiency Define preventive measures to avoid common areas of non-compliance Communication algorithm and issue escalation Plan for assessing effectiveness of any interventions or preventative methods Maintenance of quality-based standards of operations Assess defined and collected metrics for quality performance Employ intervention when required and test efficiency of intervention Root cause analysis (RCA) and proper Action Plan Documentation and evaluation of quality-based standard of operations Define the level of documentation required to assess quality performance Define the frequency of documentation to assess quality performance Assess effectiveness of any intervention or preventative measures Process approach to meet objectives Anticipated outcomes defined Mitigating risks and consequences Focus on prioritized improvement opportunities Factual approach to decision making Effective decisions are based on analysis of data and information Continuous improvement Conduct audits - contracted and internal Cost effective system to meet objectives Host sponsor audits and regulatory authority inspections All of these activities provide: Input into improving NCGS quality processes Assurance of regulatory compliance Fiscal responsibility

12 Global Strategic Sourcing NCGS global strategic sourcing solution is a hybrid model offering a customized balance of our Strategic Sourcing staffing capabilities with or without engaging our full service CRO. Strategic Sourcing provides individuals or functional teams or multi-disciplinary teams tailored around our client s specific requirement(s). Customized Solutions to Resourcing Needs Individual contract placement or permanent placement Interim/Short-term solutions for peak periods and special projects Teams developed - Functional areas, partial or full teams Dedicated staff for duration of client need / sourcing allocation Seamlessly expand limited resourcing to full service sourcing or any hybrid solution required Benefits of Strategic Sourcing Significant cost reduction compared to a fully outsourced study Reducing employment risks Increasing ability to meet project deadlines and peak periods of activity Maintaining smooth operations when staffing needs to fluctuate Flexible Billing Models Hours worked including travel if partial or fluctuating FTEs are required Per FTE for the specific duration of the assignment Billing frequency and format is negotiated in MSA All reasonable pass-through expenses will be agreed upon in the MSA Operational Gaps NCGS provides clinical research professionals across a broad range of job functions with significant industry experience, in a wide variety of therapeutic areas. Our personnel can be located at your office, NCGS office or regional field based positions. Service areas include: Clinical Management Medical Monitoring Biostatisticians Site Monitoring Drug Safety Data Management Site Recruitment / Start-Up Medical Writers CTMS Management Site Study Coordinators Quality Assurance Staff Training Grant and Contracts * etmf Management Regulatory Affairs Choosing NCGS Strategic Sourcing Staff turnover (<3%) due to high employee satisfaction NCGS tailors team processes to match client standard of operation NCGS provides highly tenured staff Sponsor has first right of access to re-assign staff members to another project benefiting from corporate intelligence Therapeutic Concentrations in Complex Arenas - Oncology, Hematology, CNS, Infectious Disease, Cardiology, Pulmonary, etc.

13 Medical Writing NCGS provides sponsors with the highest possible quality of standards-compliant, scientific documentation and medical writing services to the medical research community. Documentation is clear, concise and scientifically accurate with format and content in strict accordance with regulations and guidance. Clinical Operations Staff Protocols Investigator Brochures Clinical Sections of Regulatory Filing Documents including: Clinical study reports (Full ICH or FDA-Abbreviated) Integrated summaries of efficacy and safety Module 2 of the common technical document Full Template Support to Ensure FDA, ICH, and Sponsor Compatibility Abstracts FDA Briefing Materials NDAs in CTD format Journal Publications and Scientific Presentations Risk Evaluation and Mitigation Strategy (REMs)

14 Biostatistics NCGS provides sponsors with the highest possible quality of statistical support services to the medical research community. Clinical Development Services Design and Related Statistical Consulting for: Pre-clinical and clinical (Phases I-IV) trials Toxicity, pharmacokinetic/dynamic, and generic equivalence Analysis of results for IDE, NDA, ANDA, PMA and 510(k) submissions Assistance with Strategic Preparation for FDA Meetings Established contacts with FDA personnel Representation at FDA/Sponsor Meetings Knowledgeable of ectd Structure and Components: Required versus optional elements and structure granularity Conventions (fonts, sizes, versioning, file names, leaf elements) Experienced in building ectds and producing ectd components Documents: Modules 2,5, ISE, ISS SAS XPT files: 1999 Guidance (Raw[Listing] and Analysis) CDISC (Clinical Data Interchange Standards Committee) SDTM (Study Data Tabulation Model) ADaM (Analysis Data Model) Documentation: define.pdf and define.xml SAS programs Biostatistical Services Protocol Development, Statistical Design and Statistical Modeling Sample Size Determination Generation of Randomization Codes Statistical Programming and Analyses: Tables, figures, listings Patient profiles Integrated efficacy and safety databases Independent Statistical Team for Interim Analyses & DSMB Data Transfer

15 Pharmacovigilance Patient safety is of paramount importance in every clinical trial. Individualized safety management and reconciliation plans are developed for each study. NCGS provides sponsors with the highest possible quality of global Pharmacovigilance services to the medical research community. Global Safety Database Hosted client specific global solution (ARISg) Remote entry of cases in sponsor global safety database Comprehensive Safety Management Plans (SMPs) Including MedWatch and CIOMS reporting Clinical Trials and Post Marketed Products Expedited Electronic Reporting to EudraVigilance System Paper Based Reporting Investigators, Ethic Committees and National Authorities Annual and 6 Monthly Aggregate Trial Safety Reporting Preparation/Submission of Aggregate Safety Reports (PSUR/PADER) Signal Detection Global Literature Searches (Retrospective/Prospective) Legacy Data Upload Projects Medical Coding 24/7 Safety Call Center with Language Translation Services Global Drug Safety Database: Fully validated database with a client specific schema 3-4 weeks for set-up and testing before going live PSURs and aggregated reports are produced appropriately Remote access Runs directly with annual reports, periodic safety reports CIOMs and MedWatch reports Ad-Hoc Listing Reconciliation of Safety Database and Clinical Database

16 Thank you for reviewing this information. Our mission remains to protect research subjects, capture quality data and maintain the integrity of science with the same passion one would protect their own domain Visit www. for additional information Leadership Team Nancy C.G. Snowden CEO & Founder office (843) mobile (843) Janice Durden Senior Vice President, Clinical Operations office (843) mobile (843) David McCrary Director Business Development office (843) mobile (843) Alice Baruch Global Medical Director office (843) Kimberly Flotta Director Strategic Sourcing & Business Development office (843) mobile (703) Corporate Headquarters NCGS Incorporated 65 Society Street Charleston, SC (843) (866)