Clinical Trial Services

WEP Clinical is the leading Pharma Services Provider partnering with Sponsors from pre-clinical through the start of commercialization.

It is our mission to ensure every patient has access to treatment, be it through investigational or approved products

WEP has a wealth of experience running clinical trials and access programs for companies working with Oncology, Rare Diseases and Advanced Therapies worldwide. Clinical trials today present a complex set of challenges that sponsors must overcome. This includes managing the unique intricacies of:

Our Clinical Trial Services

Project Management
  • Therapeutically experienced PMs.
  •  Tailored project management solutions.
  • A single point of contact for all project-related inquiries.
  • Proactive risk-based project management methodology.
  • Strong Communication and Stakeholder Management.
  • Meticulous project planning process.
Regulatory Management
  • Overseen 300+ development studies worldwide.
  • Adept at navigating the diverse regulatory nuances challenges across countries
  • Practical regulatory knowledge and advice to help Sponsor develop Regulatory Strategy that meets short, mid and long-term strategic goals
  • Identification of critical timelines and risks
  • Handle all global regulatory submissions
Clinical Operations & Monitoring
  • Our clinical services are tailored to the project needs, complementing a Sponsor’s internal team and final protocol
  • Focus on site engagement.  Ensuring sites are engaged for optimal performance on your study. 
  • All monitoring activities are conducted according to the study protocol, Site Monitoring Plan, standard operating procedures, ICH GCP, and regional regulations
  • Continuous review and updating of Monitoring Plan throughout the project based on factors such as patient retention, data entry and query resolution trends, site training needs, and observed issues
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Data Management
  • Create the Data Management Plan (DMP) that ensures the capture of all data goals, regulations, and data input expectations
  • Handle Database structure design, development, validation and edit checks
  • Provide Database training and support to ensure compliance
  • Provide Data accuracy assurances and integration with other site Databases
  • Provide Database audit and lock and transfer
Biostatistics
  • Expertise in designing robust study protocols, including sample size calculations, power analysis, and randomization schemes to ensure reliable and valid results.
  • Use of cutting-edge statistical methods and software (SAS, R, Python) for thorough data.
  • Adherence to CDISC standards and other regulatory guidelines to ensure data integrity and smooth regulatory submissions.
  • Support for interim analyses and DSMBs to monitor trial progress and patient safety.
  • Tailored consultancy services for protocol development, statistical analysis plans (SAPs), and clinical study reports (CSRs).
Medical Affairs
  • Proactive, data-driven, and innovative 24/7 Medical Monitoring Services
  • Medical Consulting
  • Site Identification and Site Feasibility
  • Medical Support to Review Safety Committees
Patient Safety and Pharmacovigilance
  • Safety Surveillance for all clinical trials phases
  • Safety Database Built and Management
  • Case Processing
  • Medical Review of causality, Relatedness and Seriousness
  • ICSR/SUSAR Case Finalization and Submission
  • DSUR Listing/Reports
  • Clinical/Safety Database Reconciliation
Patient Enabling Solutions
  • Patient Recruitment Solutions
  • Remote Patient Pre-Screening and Screening
  • E-consent, Remote Assessments and Central Raters
  • Patient Concierge Services
  • Home-health services (through Wren – a WEP Clinical Company)

WEP’s Patient Enabling Solutions

Home Health Solutions

Patient Recruitment

Patient Concierge Services

Virtual Clinical Trials

Partner With WEP

Our commitment to partnership, flexibility, high-quality service delivery, and client satisfaction has resulted in repeat business in over 50% of our Sponsors.

Our success is a result of the commitment of our team to deliver high quality and service to our Sponsors. The close involvement of Senior Management at WEP ensures client satisfaction and the successful operational delivery of all studies we manage.

WEP provides our sponsors a portfolio of Clinical Trial Services and solutions to advance critically needed therapies from pre-clinical to commercialization

Tailored Solutions

We develop tailored solutions for our sponsors that address clinical and operational hurdles. These hurdles are not only unique to their current study, but also their development program.

Collaborative Approach

Our collaborative approach and flexibility creates a seamless path to ensure that access to a needed treatment is not delayed.

If you would like to chat with our team about how we can help support your development programs and create best strategies to expand access for your therapies, then please complete the form to the left or contact us at:

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