CRO Solutions

CRO Services

CRO solutions that you expect – Site ownership mentality is what sets us apart…

Global CRO services proven to work. Managing clinical needs and meeting business objectives is what we do best. Whether you’re looking for a full-service CRO solution or select CRO services to augment your existing team or Project, WCCT combines Site Ownership with clinical, medical and business expertise to develop strategic global solutions to address your company’s needs. A flexible team is what it is all about… We leverage our first-hand knowledge from our Site ownership, Patient Recruitment and study marketing departments along with Clinical operations to effectively and successful plan and execute your clinical study. Cost-effective outsourcing model that saves Sponsors 15-30% compared to industry standard, with a team you can trust.

CRO solutions include:

Clinical Project Management:

WCCT Global’s approach to Clinical Project Management is based on providing highly productive solutions delivered by qualified and talented people. We pride ourselves in having executed in such a manner for every project awarded to WCCT Global. Our approach to coordinating studies is effective planning and management. Coupled with reliable enrollment periods, and preplanned contingencies for risk mitigation –this is our culture.

Every study needs vendor participation in order to achieve success. WCCT Global views its vendors as an extension of our team to provide Sponsors the convenience of not having to manage communication with multiple vendors. Our vendors have extensive experience with WCCT and processes have been integrated and streamlined to provide efficiencies across the board. However, WCCT Global has the flexibility to work with Sponsor selected vendor(s) as well.

The goal of keeping clinical trials on track, on time and within budget is difficult to achieve without an automated system. Sponsors now recognize that to ensure investigator retention and recruitment strategies are effective they need a CRO that has an innovative approach to managing sites and studies. Come be a part of our “One World” and see how we enable sponsors and sites – to facilitate and streamline communications and collaboration with their study teams.

WCCT Global Utilizes our “One World” platform powered by @ris global™ From an intuitive dashboard, study site staff are provided with role-based access to information including TMF-related documents, training modules and records, feasibility questionnaires, and safety reports. Investigator self-registration enables sponsors to receive a steady flow on interested participants while improving relationships with existing investigators. Sponsors and site monitors can view study progress summary reports.

“One World” is a scalable comprehensive clinical trials management solution (CTMS) that enables us to plan, track, execute and control activities related to the clinical trials process. It facilitates study preparation activities such as study set-up and protocol design, site assessment, supplies management, document distribution and site visit planning from a centralized platform. As a result, we can mitigate risk and improve tracking and analysis while helping to control costs.

“One World” links to all of our other internal systems and provides a comprehensive investigator database that facilitates site and investigator selection, and maintains investigator information, including study history. Users are ensured that all clinical trials are conducted, recorded and reported in accordance with international, ethical and scientific quality standards. “One World” is fully scalable and can be integrated with other corporate systems such as SAP, finance, safety and EDC.

Our Clinical Monitors 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.

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 platforms or sponsor selected platforms while supporting the latest CDISC standards. Regardless of what system is used, WCCT’s focus is on the quality and integrity of the data collected.

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.

The objective of Biostatistics at WCCT is to advance statistical science and its application to problems of human health and disease, with the ultimate goal of advancing clinical research. With that said, our in-house Bio Statistical team has a full arsenal of strategic and tactical capabilities:

Strategic:

Extensive experience and familiarity with regulatory requirements and working with FDA and world-wide agencies and a thorough understanding of ICH / FDA Guidance Documents

Tactical:

Full library of analysis dataset, table, listing, and figure SAS programs which have been thoroughly validated

We work with the Sponsor to ensure that all programming is completed prior to database lock. Focus is on submission-ready documents

Among our CRO services, WCCT can conduct all activities associated with data summarization and/or statistical displays of the study. It is a collaborative approach.

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 manner. 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.

Lead by our Sr. VP of Translational Medicine, 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.

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

Being a world class provider of CRO services to the clinical trial arena demands hosting and licensing of cutting edge technology to keep up with the ever changing demands of our industry.

TrialOne is the number one proactive eSource and Phase I site automation solution. With real-time study data collection or SAS data exports, This web-based, tablet compatible system provides an advanced platform for automating clinic operations and complies with FDA 21 CFR part 11 as well as CDISC standards. WCCT was an early adapter of the T1 system and helped the system developer enhance and refine this platform.

– Integrated eClinical Portal

agWorld is the gateway to a unified eClinical platform that mitigates the need to deal with multiple vendors and provides users with the complete view of their trials. Leveraging single sign-on (SS0) technology, users have to remember only one username and password to access all Total Clinical solutions. With agWorld, users benefit from improved communication between peers, easy access to clinical information, streamlined operations, and elimination of redundant processes.

Total Clinical also powered by ag – leverages the latest technology advancements and evolving standards to give companies a smart, competitive edge in complying with regulations and managing trials. Cloud-based solutions for EDC, CTMS, ePRO, Supply/IWRS, trial disclosure, medical coding, and clinical safety reporting offer comprehensive functionality to deliver the benefits you seek: greater efficiency, reduced costs, faster time to market, improved control and easier vendor management.

– TrialMaster

With the most intuitive end-user experience, the most productive study design tool, flexible reporting, off-the-shelf integrations and convenient mechanisms for importing and exporting data, the TrialMaster Electronic Data Capture (EDC) Suite offers a compelling solution for electronic data capture.

– Medrio

M-1 supports rapid study configuration through a point-and-click study build interface. Utilize form libraries, study templates, and more to get your study live on time. Take advantage of Medrio’s MasterForm and avoid building multiple versions of the same form. Create one instance, choose what variables are collected at each visit, and see vast benefits upon data export where no table merges needed.

M-core supports rapid study configuration through a point-and-click study build interface. Utilize form libraries, study templates, and more to get your study live on time. Take advantage of Medrio’s MasterForm and avoid building multiple versions of the same form. Create one instance, choose what variables are collected at each visit, and see vast benefits upon data export where no table merges needed