Do you need to hire clinical operations or biometrics staff for your clinical trial?
Sofpromed is a functional service provider (FSP) for biotechnology and pharmaceutical companies conducting phase I-IV clinical trials worldwide.
We offer highly-qualified Clinical Project Managers, Clinical Trial Managers, Clinical Research Associates (CRAs), Clinical Data Managers, Study Coordinators (working at the clinical site’s facilities), Medical Monitors, Biostatisticians, and Statistical Programmers with flexible dedication and on a contract basis adapted to your specific needs.
Our FSP services are available across all therapeutic areas and in the following regions:
- United States
- Middle East
- North Africa
- Latin America
What is a Functional Service Provider (FSP) in clinical trials?
A Functional Service Provider (FSP) is a personnel sourcing model in which a clinical research organization (CRO) provides staff to biotechnology and pharmaceutical companies in order to perform specific tasks —in a dedicated manner— on a contract basis and under the procedures of the sponsor.
What are the advantages of the Functional Service Provider (FSP) model?
The advantages of the FSP model for clinical trial sponsors include the reduction of personnel recruitment and management costs, as well as quick and flexible access to highly-qualified clinical operations and biometrics staff.
These benefits are ideal for small and mid-sized biotech companies not seeking to build and maintain large in-house clinical operations, biostatistics, and data management departments, decreasing thus human resource overhead costs.
What Functional Service Provider (FSP) services does Sofpromed offer?
As a full service clinical research organization (CRO), Sofpromed offers multiple personnel roles in the areas of clinical operations and biometrics.
Specifically, we facilitate clinical project managers, clinical trial managers, clinical research associates (CRAs), clinical data managers, study coordinators, medical monitors, biostatisticians, and statistical programmers for phase I-IV clinical trials across all therapeutic areas and in most regions.
Here you can see summarized descriptions of the responsibilities of the staff we can offer:
Clinical Project Manager
- Oversees and manages vendors involved in the clinical trial.
- Supports clinical studies and works with cross functional teams.
- Controls major project milestones, identifies potential risks in advance, and proposes mitigation strategies.
- Resolves study related problems, escalates issues to upper management, following up until resolution.
- Writes protocol amendments and/or makes changes to ICFs as needed.
- Supervises all study activities from study initiation through close out, including site selection, monitoring study compliance, cost management, document oversight, monitoring of trial data, and verification of close out tasks.
Clinical Trial Manager
- Manages clinical site selection, study start-up, enrollment aspects, site engagement, monitoring plans, regulatory documentation, data cleaning activities and close-out.
- Ensures completion of trial deliverables.
- Guarantees appropriate communication and oversight of clinical trials by working with the sponsor and other functional team members.
- Trains team members.
- Identifies challenges to study timelines and offers effective solutions.
- Leads and supervises CRAs as they establish relationships with clinical sites for high quality site management and monitoring.
- Maintains the focus on study priorities and ensures the highest level of customer satisfaction.
Clinical Research Associate (CRA)
- Prepares and submits clinical trial documents to EC/IRB and to Regulatory Authorities.
- Conducts site qualification, initiation, monitoring, and close-out visits.
- Trains and supports Investigators and site staff in study procedures.
- Ensures sites are audit/inspection ready at all times.
- Identifies study-related issues and escalates them to Project Manager / Sponsor, following up until resolution.
- Updates CTMS and other trial systems.
- Manages study files, drug supplies and drug accountability at clinical sites.
- Performs remote data checks through eCRF reviews.
- Performs onsite and remote source data verification (SDV).
- Ensures data query resolution in communication with sites.
- Reports and manages protocol deviations.
- Works with data management teams to ensure high quality data.
- Ensures timely reporting of Serious Adverse Events.
- Distributes annual safety reports to involved parties.
- Completes monitoring visit reports and provides feedback to clinical site staff.
- Follows up on outstanding actions with study sites.
- Helps sites in maintaining inspection ready ISF.
- Collaborates with the activities related to audits and inspections.
- Ensures collection of essential documents and their upload into the eTMF.
- Ensures study compliance with applicable legislation.
Clinical Data Manager
- Works on all aspects of the clinical trial data management process from pre-study start up to post database lock.
- Develops Case Report Forms (CRFs) and data cleaning strategies.
- Is involved in clinical database development and user acceptance testing (UAT).
- Performs data cleaning via query management.
- Implements and tests electronic data capture (EDC) systems based on internal procedures.
- Creates and/or reviews study-specific data management and database documentation, including Data Management Plan, CRF Completion Guidelines, Coding Guidelines, Annotated CRFs, and Edit Check Specifications.
- Performs medical coding of terms such as adverse events and concomitant medications.
- Trains Investigators and/or Study Coordinators at Investigator Meeting on the EDC system.
Study Coordinator (working at the clinical site facilities)
- Coordinates clinical trial activities at the clinical site.
- Performs data entry in the EDC systems.
- Maintains accurate records related to ethics and regulatory requirements.
- Conducts patient visits, completing all clinical procedures.
- Manages patient informed consent form (ICF) signature processes.
- Maintains current reports of enrollment and study progress.
- Maintains the Investigator Site File (ISF).
- Manages trial-related software tools.
- Attends Investigator meetings.
- Recruits and schedules subjects for the clinical trial.
- Ensures that all protocol procedures are completed per protocol and according to GCP guidelines.
- Works with monitors as required and responds to data queries.
- Provides support for biological sample management and study logistics.
- Offers medical expertise for the clinical trial.
- Provides support for the rationale, objectives and design of the clinical protocol.
- Assumes responsibility for safety activities including reviews of serious adverse events and annual safety reports.
- Addresses safety issues across the study.
- Participates in the Data and Safety Monitoring Board (DSMB) meetings.
- Provides support to confirm patient eligibility criteria in the clinical trial.
- Works with project teams to meet study deliverables and timelines for statistical data analysis and reporting.
- Provides statistical advice regarding clinical study design, study endpoints, sample size requirements, statistical methodology for the study protocol and the clinical study report.
- Develops statistical analysis plans (SAPs).
- Provides data analysis and presentation methods to support publications/presentations.
- Develops and implements the randomization code (including randomization plan).
- Works on the Statistical Analysis Plan (SAP).
- Performs statistical programming tasks (generation of tables, figures, and listings, including reports).
- Provides study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM)-specific services for clinical data submissions to the FDA.
- Contributes to the Annotated CRF.
- Develops mapping specifications.
- Is in charge of SAS programming, double programming, data validations and transfers, the development of the Clinical Study Data Reviewer’s Guide, and Define.xml
How much do Sofpromed’s FSP services cost?
How are Sofpromed’s FSP services hired?
Biotech and pharma companies can hire our FSP services by following these steps:
- Download our FSP price list or contact us to specify your staff needs
- We will send you the CVs of the roles requested along with detailed cost information
- You can have an interview with the proposed candidate
- A contract is signed between the biotech/pharma company and the CRO
For more information about FSP services please contact us at firstname.lastname@example.org