Services

Phase II-IIIA

Clinsys® is a full-service clinical research organization (CRO), providing a broad scope of services needed for conducting a clinical trial in the shortest time possible. Clinsys offers comprehensive clinical trial management, clinical trial design, scientific/medical support, data management, biostatistics, medical writing and quality assurance services to the pharmaceutical, biotechnology, and medical device industries.

Clinsys provides the resources needed to successfully design, conduct, analyze and report the results of your clinical trial. We work closely with our clients from the start to assess their needs and customize a program of services to meet those needs. Whether projects are large or small, we provide a complete program or individual services for any part of a trial.

Clinical Operations

Clinsys offers site management and study monitoring across the United States, Europe and India through our network of clinical research associates (CRAs). Our CRAs are regionally based, which enables them to maximize their on-site time, reduce travel costs and, most importantly, develop excellent relationships with the investigators and staff at study sites.

Clinsys' project managers are the leaders of cross-functional project teams. They have complete responsibility for ensuring that projects are completed on-time, within budget and scope, and with the highest level of performance and quality. With an average of 8-10 years experience in the industry, Clinsys' project managers have excellent communication, planning, implementation, and problem-solving skills.

We conduct all of our projects under a project management methodology called the Global Project Solution® (GPS). Developed internally by Six Sigma-trained staff, GPS allows us to provide clients with a standardized approach to project management.

We have so much faith in our methodology that we utilize it globally ourselves when new processes or technologies are rolled out.

Biometrics (Data Management & Biostatistics)

Our data management and biostatistics services are governed by rigorous SOPs and comply with ICH, GCP, and FDA 21 CFR Part 11 regulations.

Clean data—on-time and on-budget—is what Clinsys delivers to each client. An experienced group of data managers, programmers, data entry professionals and Ph.D. statisticians are assigned to each project and they stay with that project from inception to completion.

Clinsys uses the commercially available and vendor-supported ClinPlus® suite of software programs for managing clinical data. Data is inputted, managed, analyzed, and reported in SAS®, the preferred format of the FDA. In the hands of our experienced data managers, this fully validated database system allows Clinsys' data management to output only the highest quality data. ClinPlus is fully compliant with 21 CFR Part 11 requirements. Clinsys also provides electronic data capture (EDC). Biostatistical information is provided via a combination of appropriate state-of-art software, such as SAS, nQuery Advisor, PASS and StatXact, utilized by statistical programmers who are knowledgeable of the latest programming techniques and software features.

Regulatory Services

Clinsys has significant experience in full-service regulatory consulting, especially in the areas of strategic drug development, clinical development plans, medical writing and communication.

Regulatory Submissions
  • Clinical Trial Applications (CTX, IND)
  • Marketing Applications (NDA, BLA, NDS, MAA)
  • Regulatory Safety Reporting and Post-Marketing Surveillance
  • Orphan Drug Designation Requests
FDA Liaison Activities
  • Regulatory AgentSponsor Representative
  • Meeting Preparation
  • Meeting Packages

Safety and Medical Monitoring

Serious adverse event (SAE) management and reporting processes for a trial are detailed in the Clinsys global safety plan. This plan provides comprehensive guidelines to ensure SAEs are reported and processed accurately and that appropriate follow-up measures are taken so resolution is achieved. The plan was developed in conjunction with safety personnel in the US, Europe and India, and coordinates and accounts for the different practices and procedures in each locale. Additionally, Clinsys has prepared a safety management plan that describes the minimum and necessary requirements for all safety processes and allows for a customized safety plan specific for each study.

For each trial that requires medical monitoring services, Clinsys assigns a medical monitor(s) who has experience in the therapeutic area specific to the study or who has some area of expertise that is required for the study. Clinsys has immediate availability and in-house medical monitoring capabilities in the US, India and Germany, and has access to medical monitor coverage and capabilities in other countries in Europe.

Quality Assurance and Compliance

Clinsys' Quality Assurance and Compliance group has established systems and processes to ensure that clinical work is performed and data are produced in compliance with all applicable regulations, guidelines, Clinsys/sponsor SOPs and client contracts. Our experienced quality assurance professionals work with our clients to conduct internal and external GXP auditing: Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Our Quality Assurance and Compliance department audits all studies Clinsys performs according to FDA regulations and ICH guidelines. Audits are conducted according to Clinsys/sponsor SOPs and client contracts.

Clinsys is committed to conducting business in an ethical manner and complying with state, federal and local laws and regulations. We have established Codes of Conduct for all employees, from entry level to senior management, and provide necessary training to ensure compliance. In addition, an e-mail address (compliance@clinsys.com) has been established to field complaints and concerns from employees and third parties. Investigation of all suspected non-compliance offenses will be documented and reported as necessary, and prompt corrective action will be taken as warranted.

Clinical Research Associates (CRAs)

Our CRAs typically have backgrounds in nursing, life sciences or pharmacy. Over 60% have more than three years of monitoring experience in a wide variety of therapeutic areas. Many started in clinical research as study site coordinators at large academic centers. A majority of our CRAs are certified by the Association of Clinical Research Professionals (ACRP). Monitors are continually screened by our team of in-house recruiters, providing the ability to quickly meet demand for additional clinical monitoring capacity at crucial times in a study.

Our CRAs receive on-going training in regulatory compliance, FDA regulations, ICH guidelines, Good Clinical Practice (GCP), and the Health Insurance Portability and Accountability Act (HIPAA).

Clinsys CRAs conduct all aspects of clinical monitoring, including:

  • Visits (pre-study, initiation, interim and close-out)
  • Site personnel training
  • Source documentation verification
  • Regulatory document review
  • Drug accountability
  • Site management

In addition to these clinical operations, Clinsys provides independent case report form (CRF) transcriptionists on site to complete CRFs and resolve queries. We also assemble a monitoring team to conduct drug accountability visits, thereby maintaining the blind study for the monitoring and investigative staff.

Project Managers

Clinsys' project managers utilize our global capabilities, processes and systems to ensure quality throughout the life of the project. Implementation of a risk management strategy at the start of each project is standard for Clinsys and utilized to strategically address potential obstacles. Based on our GPS methodology, risk evaluation is a process that continues through to the final deliverable.

Clinsys is a therapeutically focused CRO, and each project manager is selected based on the experience and skill set required for each project. The project manager leads a dedicated team of professionals from each discipline, including clinical operations, regulatory, data management, biostatistics, medical communications, and quality assurance. In addition, a therapy area project director is assigned to each study to provide leadership and ensure customers receive the quality of service mutually agreed upon.

Our project managers are fully accountable for their projects—in fact, they "own" them. Experience has shown that our strategy of project ownership results in strong commitment, a proactive management style, and the highest level of performance by our managers.

Project Manager Responsibilities

  • Prepare and track project timelines and milestones
  • Develop and review protocols
  • Develop project plans (project management, adverse event reporting/safety)
  • Train CRAs and site personnel on protocol, CRF conventions, and SOPs
  • Recruit investigators and sites (coordinating the process of identifying and contacting potential investigators and making recommendations to the sponsor)
  • Conduct/organize investigator meetings
  • Supervise administration of grant payments to investigators
  • Manage and supervise CRAs on the assigned projects to ensure high quality and consistency across centers
  • Review letters and monitor visit reports from CRAs and periodically co-monitor sites
  • Develop contingency strategies and proactive solutions for project challenges
  • Maintain the Clinsys clinical trial management system (TrialWorks)
  • Establish project communications and reporting systems specific to sponsor needs and requests
  • Coordinate investigational product/clinical supplies shipments
  • Manage contract budgets
  • Disseminate SAE information to the sponsor and CRAs

Data Management

Because our data management professionals are integrated into the project team from the very beginning, communication is enhanced and areas of concern are identified and avoided, resulting in maximized data accuracy and integrity. Clinsys' data management personnel provide customized weekly tracking and progress reports to keep sponsors fully informed on the progress of their studies.

Start-up

  • Develop and review CRF and CRF completion guidelines
  • Provide CRF in PDF format for publication and distribution
  • Implement CDISC standards
  • Provide a written data management plan
  • Program and validate database structure, edit checks and data transfer process from third-party vendors
  • Perform test transfers of the database, if necessary

Production

  • Barcode and track each CRF and data resolution form page uniquely
  • Perform ongoing double and independent data entry
  • Resolve data entry discrepancies
  • Run automated edit checks and perform manual CRF review
  • Generate queries to the study sites and resolve queries
  • Code adverse events (MedDRA, WHO-ART, COSTART)
  • Code concomitant drugs (WHODRUG) and procedures
  • Clean data transfers as frequently as needed, with study closure

Study Closure

  • Conduct 100% QC audit of all key safety and efficacy variables
  • Freeze the database
  • Review protocol deviations and/or violations
  • Lock the database
  • Extract SAS datasets for analysis

Biostatistics

Clinsys is proud of its ability to provide clients with rapid turnaround of accurate data analysis and interpretation. The average time from database lock to delivery of top-line tables is five working days. The statisticians at Clinsys have the industry experience, 12 years on average, necessary to design and develop a rigorous statistical analysis plan for each project, regardless of size or complexity. All design, analysis and reporting is based on ICH guidelines, FDA requirements, client needs and Clinsys SOPs.

Statistical Aspects of Study Design

  • Design alternatives: parallel, crossover, split-design, up-and-down, open label single arm and multiple arm studies
  • Statistical methodology section in the protocol
  • Power analysis and sample size calculation
  • Randomization
  • CRF review

Statistical Analysis Planning

  • Analysis planning meetings
  • Methodology development and evaluation
  • Production of analysis plan
  • Production of mock tables, listings and graphs
  • Statistical analysis

Data Analysis

  • Analysis dry-run
  • Programming DDS (derived dataset)
  • Formal interim and final analyses
  • Tables, listings and graphs programming
  • Post-hoc and exploratory analyses
  • Blind review of protocol violations
  • Independent validation through double programming and peer review
  • Conversion of final product in Word, PDF or other desired formats
  • ISS and ISE analyses
  • Abstract analysis, writing and publication
  • PK/PD/BA/BE and propensity analyses
  • Interface with regulatory authorities as necessary

Reporting

  • Full and abbreviated statistical reports
  • Integrated clinical and statistical reports
  • Sponsor, FDA and advisory committee presentations

Quality Control Services

  • Review and quality control of client analysis and report
  • Independent reprogramming and review

Quality Assurance and Compliance

Auditing Services

  • Domestic and international GXP auditing
  • Routine and for-cause audits
  • Process/systems audits (monitoring, safety, drug accountability, etc.)
  • Investigator site audits
  • Vendor audits and due diligence assessments (Central Laboratory, Central IRB, CRO, central reading facilities, drug packaging/distributions, etc.)
  • Trial master file audits
  • Database audits
  • Safety audits
  • Clinical study report audits
  • Regulatory submission audits (CTD, NDA, MAA, BLA, etc.)

Quality Systems Services

  • GAP analysis
  • Quality systems development and maintenance
  • SOP development
  • Quality systems audits

Other Services

  • Training programs and presentations
  • Corporate compliance program development and maintenance
  • FDA/RA inspection preparation
  • Mock FDA/RA inspections
  • Facilitation of FDA/RA inspections