Therapeutic Experience & Countries Served:

Our staff has been involved in studies for: Rett Syndrome, Autism, OCD, Fragile X, Oncology, Pain (Post-Operative, Oncological, and Neurological), Diabetes (control, diagnostics, delivery, and neuropathy), Allergy (relief and diagnostics), Gastrointestinal, Prostate, Sexual Dysfunction, Traumatic Brain Injury (mild and acute), Cardiovascular, Eye (Retinopathy), Dermatology, Anesthesia, Surgical techniques, Vaccines / Immunology, HIV, HCV, and Specialized Devices.

Data has been collected from around the world. Countries include are: Australia, Austria, Belgium, Canada, Chile, China, France, Germany, India, Japan, Romania, United Kingdom, and United States.

Project Management:

Focus on providing on-time, on-budget, quality deliverables; Expert project management skills; Wide Therapeutic expertise, transparent communications, Agile team that is responsive and accommodating; Collaboratively work together to meet objectives; Tenured resource, budget and timeline management; Steadfast knowledge of applicable regulations, technologies and business processes; Consultative support for investigators; Vendor management and coordination

Clinical Operations:

Focus on providing on-time, on-budget, quality deliverables; Collaboratively working with sponsors and communicating every aspect of our monitoring activity throughout the engagement; Managing the clinical aspects of the study to collect clean and quality data; Managing all site-related activities, visit schedules and report preparation; Proactively identifying and resolving study-related issues; Supporting and encouraging sites; Keeping projects on track; Mentoring CRAs and monitoring quality, Timely obtaining signed informed consent forms; Sourcing data verification (SDV), based on the protocol SOP; Reviewing all eCRFs and discussing trends with site staff; Evaluating eCRFs for serious adverse events; Performing investigational product accountability; Reviewing investigator study files for completeness, Reviewing protocol compliance

Regulatory Consulting:

Review IND, CSR, and NDA submissions. Assisted with FDA meeting and other interactions.

Data Management:

Assures the overall accuracy and integrity of the clinical trial data; Affordable; flexible electronic data capture (EDC) and study management software; Flexibility to meet your study needs; Complete visibility and management throughout the project life cycle; EDC implementation best practices; Project management to ensure data quality and successful study completion; Case report form (CRF) development; Clinical/medical coding with industry standards (MedDRA, ICD, etc.); Data validation and query resolution using Clarity Stack clinical technology; Data cleansing and quality assurance auditing, Complete management of EDC audit database; Project-specific data dictionaries; Reconciliation of external data; Data preparation for statistical analysis including derived variable creation and SAS programming; Site audits for data integrity; Paper and Electronic capture, Phase I-III studies and Device trials; Existing legacy studies (spreadsheets, ascii files, and paper CRF’s) and planned studies integrated into integrated safety (ISS) and efficacy (ISE) SAS datasets for NDA filing.

Data Entry Software:

We have a long-standing relationship with Merative, the producers of Zelta EDC (formerly IBM Clinical Development), which accelerates EDC deployment for data and document processing.

Statistical Analysis Plan Review:

82 international studies in post-operative settings reviewed for global NDA filing.

Quality Assurance & Vendor Audits:

Virtual/Remote or onsite vendor audits and qualification assessments (eg: CROs, specialty technology suppliers, patient recruitment and retention, clinical laboratories), computer systems validation, privacy, SOP review and gap analysis, site audit (including "for cause"), clinical operations, data management, and statistical analysis (analysis plans, models/assumptions, SAS or R programming).

Clinical Presentation Preparation for Professional Associations:

These include: The American Urological Association, Royal Academy of Science, American Public Health Association, and European Congress of Allergology & Clinical Immunology.

Custom SAS Programming /Drug trials:

Data integration, client presentations.

Coding of Medical Terms:

Migration of legacy data to MedDRA and WHO drug dictionary.

CRF Validation / Hazard Plan:

Assessment, remediation, testing and implementation.