Pharmacovigilance

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Pharmacovigilance Services

Our vision is to be recorded among the top pharmacovigilance reevaluating and Outsourcing organizations. We are continually working towards our vision. Unarguably, we have the information and we have the mastery our Crewexcel team, Subsequently, Bring the best arrangement while considering rethinking on outsourcing pharmacovigilance Projects We want to assist our clients with meeting the regulatory requirements and administrative necessities, alongside dealing with all bottlenecks, benefit profile of their items, to augment item potential, while guaranteeing client overall wellbeing.

What we Offer:

Human Resource Solutions

  • Full or part-time, short or long-term staffing solutions for teams and individuals
  • Dedicated special project teams
  • Customized FSP Services
  • Study rescue teams
  • CRO Oversight
Functional Solutions
Data management
Biostatistics
Medical writing
Pharmacovigilance
Stand-alone or bundled services
Seamless use of Catalyst SOPs, systems

Our Expertise:

  • European Economic Area (EEA)
  • Risk Management
  • Qualified Persons for Pharmacovigilance (QPPV)
  • Local QPPV, Safety data exchange agreement (SDEA)
  • Development of risk management plans (RMPs)
  • Development of pharmacovigilance system master file (PSMF)
  • Development of standard operating procedures (SOPs)
  • Post-marketing and Clinical trial case processing
  • Validated safety databases

Our services in Clinical Data Management include:

Our CRF Process:

One of the most valuable assets in clinical research is trial data. The quality and integrity of clinical data is directly impacted by the case report form (CRF) instruments used to collect them. A data collection tool whether paper or electronic, is only valuable if it collects data accurately and efficiently. Data collected that is not relevant to the protocol or does not answer the protocol endpoints results in delays and increased cost. Crewexcel designed to provide the unique opportunity to hear from a variety of perspectives on the challenge and goal of successful CRF design. The topics will cover general introduction of CRF development, CRF layout designing, placement of CRF elements, CRF annotation process and standard CRF development strategy etc. Crewexcel address and provide solutions to discuss real-life problems and solutions in day-to-day CRF design.

Clinical data management (CDM)

CDM is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free. The goal is to gather as much of such data for analysis as possible that adheres to federal, state, and local regulations.

The field of clinical data management (CDM) has come about due to demands from both the pharmaceutical industry and the regulatory authorities. As the drive to “fast-track” the development of pharmaceutical products continues to accelerate, regulatory entities have responded by requiring quality-assurance standards to be met in collecting the data used in the drug evaluation process.

OUR Crewexcel team have hands on experience dealing Full life cycle of CDM Process, we know what a Great Team should hold and requires a variety of roles and responsibilities of team members and take the form of:

Data manager– supervises the CDM process
Database programmer or designer– performs the CRF annotation, creates the study database, enables data validation, designs.
Medical coder– codes variations such as adverse events and medical history
Clinical data coordinator– designs the CRF, prepares the filling instructions, develops discrepancy protocols
Quality control associate– checks the accuracy of data entry and performs data audits
Data entry associate – tracks the receipt of CRF pages and enters data into a database