Veracord
Clinical Services

BIOSTATISTICS

Our biostatistics services involve producing statistical analysis plans, generating tables, listings and figures, and performing statistical analyses. Veracord can provide people onsite under your direction, or offsite. Our statisticians focus on protocol design, calculation of sample sizes, power calculations, and/or the production of a study randomization. We have consultants with a wide range of therapeutic experience, including device.

STATISTICAL PROGRAMMING

Veracord's statistical consultants are SAS Certified (Base and Advanced) Programmers. They are highly skilled in the design and analysis of Phase I-IV clinical trials with varying designs, such as parallel group, cross-over, Bayesian designs, pharmacokinetic/pharmacodynamic evaluations, therapeutic equivalence testing, and sequential designs. They are very knowledgeable in CDISC and AdAM mapping, tables, listings and figures, CRF annotations, as well as regulatory e-submissions.

DATA MANAGEMENT

Our clinical data management and consultancy services are dedicated to providing you with clinical data, data analysis, regulatory support and presentation requirements. We have extensive data management experience for Phase I-IV clinical trials across a range of therapeutic areas and quantitative methods. Our services include Electronic case report form (eCRF) design, database design and study setup, clinical coding with industry standards, reconciliation of external data, data validation and query resolution, and project management of data and technical services

DATABASE DESIGN

The database consultants at Veracord can assist in end user analysis, defining data elements, understanding the relational model, queries, security (HIPAA), maintenance and other areas of concert in your critical database area.

REGULATORY AFFAIRS

With ever changing regulations from the FDA and other international governing bodies, regulatory compliance is a complicated task. Our consultants provide strategic planning, on-site monitoring and regulatory agency interaction. We have former FDA auditors with vast experience in regulatory. We can also assist with regulatory submissions (IND, NDA, BLA, ANDA, IDE, PMA) or annual reports.

MEDICAL WRITING

Regulatory Medical Writing services are available for reviewing or writing the packaging inserts, labels or advertising copy to ensure they follow all regulatory guidelines so you don't fall outside of the current requirements for labeling or advertising.Regulatory Medical Writing services are available for reviewing or writing the packaging inserts, labels or advertising copy to ensure they follow all regulatory guidelines so you don't fall outside of the current requirements for labeling or advertising.

MONITORING / CRA'S

Veracord has top notch CRA's who have extensive industry experience in top BioPharma companies. They practice a risk based approach to Monitoring and Site Management. We have consultants across the therapeutic board including Oncology, Cardiovascular, Pulmonary, Endrocrinology, Pain, Immunology, and Rheumatology, among others.

PROJECT MANAGEMENT

The industry is placing new demands Project Managers to oversee the entire clinical trial process, often including complex relationships with many stakeholders, including multiple sponsors, Contract Research Organizations (CROs), Academic Research Organizations, etc. Our PM's

VALIDATION

Veracord offers a whole suite of validation services in the clinical setting, from GCP in data management to the underlying IT Systems. Our experts in GCP can assist on any of your clinical validation and compliance initiatives.