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:
- The disease itself
- Clinical trial design and execution
- The ever-changing global regulatory environment
- Distribution and logistics
Our Clinical Trial Services
- 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.
- 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
- 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
- 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
- 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).
- Proactive, data-driven, and innovative 24/7 Medical Monitoring Services
- Medical Consulting
- Site Identification and Site Feasibility
- Medical Support to Review Safety Committees
- 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
Partner With WEP
We build our clinical trials with patients in mind. As part of our service offering, we provide a number of solutions to help improve the patient experience when participating in research studies. These include:
Home Health Solutions
Patient Recruitment
Patient Concierge Services
Virtual Clinical Trials
Our patient-first approach, coupled with our commitment to partnership, flexibility, and high-quality customer service, has resulted in repeat business in over 50% of 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.