PROJECT MANAGEMENT

Kaplan Research and Development research project and program management requires a broad range of skill and expertise if various disciplines in order to plan, administer, track, evaluate and report activities and budgets new drug or medical device development process. Our project management team members with a variety of backgrounds have vast experience in managing various clinical studies, anywhere from first-in-man trials to multi-country phase IV studies. Our Project Managers work effectively and diligently to handle all critical aspects of the study to ensure on-time delivery of results, within budget and with the highest possible quality output.

• Diligent planning

• Clear communication

• Proper execution

• Proactive Solutions

• Responsiveness

REGULATORY AFFAIRS

Kaplan Research and Development has dedicated resources which enable us to provide regulatory solutions to support your product development programs. We provide comprehensive regulatory services across the spectrum of global product development, registration and commercialization. With regulatory experience spanning all areas of pharmaceuticals, our global regulatory experts provide intelligence and strategic insight to optimize your product's success.

Our regulatory services include:

• Development of regulatory strategy
• An initial assessment of your data to maximize the possibility of rapid clinical trial approval
• FDA regulatory submission preparation / review / e-submissions: IND, BLA, NDA, ANDA, PMA IDE, 510(k)
• Marketing authorization applications
• Non-US Regulatory Submissions
• Country selection / local regulatory consultancy and timeline guidance
• Submission for clinical trial approvals and regulatory agencies interactions worldwide
• Study drug and supplies importation and exportation
• Advisory Services

CLINICAL SERVICES

Kaplan Research and Development provides comprehensive study monitoring and site management services. Our skilled and well-trained monitors support the entire study life cycle from investigator selection through database closure and ensure the highest quality review of data and effective interaction with study sites. We monitor investigator sites throughout the US, Baltics, and Eastern Europe. All monitoring activities are conducted according to GCP, ICH and FDA requirements. Our processes are designed to be cost effective so each on-site visit is determined by the needs of the project and the site's activity.

MEDICAL MONITORING

Our highly experienced clinical research physician worldwide network provides medical support and training to study team and assure the complete, consistent and timely assessment and documentation of adverse events. Medical Monitoring services at Kaplan Research and Development include:

• Subject eligibility review
• Handling requests for protocol deviations
• Review of reported serious adverse events
• Preparation of safety reports
• Reporting to regulatory authorities as required
• Adverse event narratives
• Reconciliation of adverse events with case reports and safety database
• Medical review of trial related documents and clinical reports
• 24-Hours/7-Days coverage

MEDICAL WRITING

Kaplan Research and Development provides professional medical writing and publishing support in preparing regulatory documentation for submission to international regulatory agencies in eCTD format and according to ICH guidelines for structure and content of clinical study reports (ICH-E3).
Our medical writing services include:

• Investigator's brochure preparation
• Clinical study protocol
• Clinical study reports
• Publication manuscripts
• Literature reviews
• Poster presentations

DATA MANAGEMENT AND ANALYSIS

Data Management and Analysis is an important element of our portfolio. Every clinical study and program requires a thoughtful review and recommendation of the most efficient, cost-effective data capture technologies. Kaplan Research and Development can provide comprehensive data management planning prior to study initiation in order to maximize data collection and processing efficiency. We are committed to providing customized data management services to accommodate our partners. We consult on and offer as part of our data management services for traditional paper-based CRFs, EDC systems as well as data integration with other data systems such as central laboratories, central readers, IVRS, etc.

Our experienced in-house and well-known subcontract statisticians are available to work with our clients through various stages of the clinical study, including study design, interim data transfers and analysis, final statistical analysis and reporting stages of clinical trials.

QUALITY ASSURANCE AND AUDIT

Kaplan Research and Development is a global clinical research organization providing a full range of independent GCP audit capabilities and quality assurance support.  Kaplan Research and Development has developed proven systems approach methodologies for the conduct of investigator site, clinical research organizations, data management and analysis, central reading facilities, central laboratory facilities, software systems and drug supply management audits.   These services provide enhanced quality standards, optimize clinical trial effectiveness and minimize regulatory risk.  Our GCP audit experts cover the globe including: North America, Europe, India, Eastern Europe including Russia and the Baltics.  Clinartis performs GCP audits against FDA 21 CFR requirements, ICH E6, ISO 14155, local regulatory requirements and standard operating procedures.  Clinartis’s approach to conducting GCP audits includes the following deliverables:

• Development of a comprehensive audit plan,
• Audit report and audit certificate issuance,
• Corrective and preventative action recommendations.

Kaplan Research and Development, LLC