Global CRO solutions that work… – managing clinical needs and meeting business objectives. Whether you’re looking for a full-service CRO solution or select services to augment your existing team or Project, WCCT combines clinical, medical and business expertise to develop strategic global solutions to address your company’s needs. WCCT’s CRO team is also flexible to work with non-WCCT sites; SMOs, independent research sites, KOLs, academic and university-based centers. We leverage first-hand knowledge from our Site ownership and site operations along with strategic Patient Recruitment to effectively and successful plan and manage your study. Cost-effective outsourcing model that saves Sponsors 15-30% compared to industry standard, with a team you can trust.

Project Management

WCCT’s approach to study management is based on our patient-centric perspective.  Starting with the patient, then the site, then recruitment and ultimately the CRO services needed, WCCT is focused on what the study really needs: patients/subjects.  Each study is managed by a dedicated team to your study, avoiding the conflicted commitment that comes from shared resources.  We are also committed to team consistency – with nearly 100% staff retention.  CRO team experience averages 15+ years of related industry experience, across diverse therapeutic areas of expertise and are further supported by an executive team that is Physician lead. Prioritization and involvement From the top throughout the study duration.

 Monitoring

Our Clinical Monitors (CRAs) include of a blend of in-house FTE’s and full-time contractors.  They are highly skilled, therapeutically aligned, centrally trained and committed to excellence.  We have regionally positioned our team to reduce or eliminate travel costs while maximizing visit productivity and quality.  Quality people and solid processes ensure the integrity of your study. The WCCT Monitor is knowledgeable of all aspects of the study, flexible to meet your needs, and focused on the safety of Subjects.

 

Data Management

 WCCT offers cutting edge electronic data capture (EDC) solutions giving Sponsors options based on cost, timelines and clinical strategy.  We are flexible to implement our own data management system, TrialOne™ which offers a web-based interface allowing for quicker decision making, extensive reporting functionality and on-demand data export capabilities supporting the latest CDISC standards or utilize a Sponsor’s proprietary system; or collaborate with a preferred third party vendor.  Regardless of what system is used, WCCT’s focus is on the quality and integrity of the data collected.

TrialOne helps drive efficiencies and reduce costs through faster volunteer recruitment, flexible screening questionnaires, direct data capture at our sites, work flow automation and modern data processing. The stream-lining of processes allows us to save time and money while increasing quality through enhanced user prompts leading to fewer mistakes and less data queries.

As a full service Data Management provider that leverages Best in Class Systems, People and Processes to provide a comprehensive, cost effective End to End solution. System independent, Our service offering includes:

Development of the Data Management Plan (DMP), Database design,  Preparation of the Data Validation Plan (Edit check specifications), CRF/eCRF design, Database design, Data Entry of CRFs (paper system), Data Review, Generate/track/reconcile data queries, Provide coding dictionaries for AEs (MedDRA) and medications (WHO Drug) and perform data coding of all AEs and medications, Data reconciliation, data transfer specifications, Interim analysis, Lock database,  Transfer final datasets to biostatistician

 

BioStatistics & Analysis 

At WCCT, we know the importance of providing an experienced team.  We also know the importance of providing cost sensitive solutions to the Pharma and Bio-tech industry.  That is why we offer 2 distinctly different models when it comes to Statistical Services.  Being a global company, we have the ability to offer on shore or off shore model when it comes to Statistical Services.  Both models provide the same types of services, all lead by our internal people, processes and quality.

WCCT can provide services for conducting all activities associated with data summarization and/or statistical displays of the study. It is a collaborative approach : WCCT and the study sponsor will collaborate on the development of a Statistical Analysis Plan (SAP). The biostatistician will also review the study protocol and provide, or review, the protocol description of a statistical analysis of the study data appropriate to the study objectives. The biostatistician will review the sample size of the study to advise the sponsor regarding its adequacy for achieving the protocol objectives.

The Statistical Analysis Plan (SAP) will includ a detailed description of the targeted study population and statistical methodology to be used, methods of computation of all analysis variables, handling of missing values and outliers, handling of multiplicity issues, identification of primary and secondary analysis variables, identification of analysis populations and subsets, and methods to ensure blinding and control of Type I error rate for any interim analyses. The SAP will also include templates or formats for proposed summary tabulations of the data and data listings to be included in the clinical study report. The SAP will include data definitions for all analysis data sets not already described in the Data Management Plan.

The biostatistician will author a test programming code for preparation of tables, listings, and figures, and performance of statistical analysis of the study data according to the SAP.  The biostatistician will perform an independent statistical review of the clinical database and provide review comments for resolution to the CDM prior to database closure. After the authorized database lock, the biostatistician will merge the randomization codes, and develop the planned tables, listings, and figures.  WCCT QA will perform an independent audit of the tables, listings, and figures, to confirm their correspondence and agreement with the SAP and the study database.

The biostatistician will collaborate with the medical writer to ensure that statistical methods and results, and any changes in statistical methods or special circumstances, are properly related in the clinical study report.

 

Pharmacovigilance

At WCCT, patient safety is our top priority.  Through extensive medical evaluation and review, we provide Sponsors with data that is clean and error free and reported in a timely monnor.  Specializing in data capture, analysis, trend detection, and reporting, we work with our clients to conduct studies, analyze information, and prepare the appropriate reports. Our medical professionals work closely with pharmaceutical companies and CROs, providing support and expert advice during each phase of drug safety development and analysis process.

 

Regulatory Affairs Services

Lead by our Sr. VP of Reach and Development, our experienced Regulatory Affairs team can help you with regulatory submission strategies and preparation, regulatory meeting preparation and attendance. With a broad range of therapeutic expertise, our capabilities include clinical trial design, clinical operations management, and experience with studies from Phases I-IV.

-IND Services WCCT’s IND team provides expertise and resources to help early stage clients bring late discovery products into clinical development.  Our three-parallel process enables the team to multi-task the three elements of Drug Development simultaneously for maximum efficiency, leading to reduced timelines and cost savings. Services include chemistry, FDA Pre-IND meeting preparation, IND submission and clinical trial launch.

 

Medical Writing

WCCT’s Scientific Advisors and Biostaticians work with our clients to develop a sound scientific approach to your program or study.  Our services include 2 distinctly different models when it comes to Medical Writing activities.  Being a global company, we have the ability to offer on shore or off shore services when it comes to Medical Writing.  Both models provide the same types of services, all lead by our internal people, processes and quality.

Protocols/Case Report Forms/Investigational Brochures/Informed Consents/Pre-IND Packages/IND Submissions/FDA Meeting Notes/Annual reports/Final Study Reports/NDAs/ BLAs/ PMAs/Product assessments/gap analyses/Medical alert letters