SterlingBio offers Clinical Trial services outsourcing for BioPharma product development. Our services offering is summarized below. Our Team has in-depth clinical trials industry experience with functional expertise in the following areas:
ETMF Project Management
At SterlingBio, we are committed to providing our clients with the highest quality service and support. Our goal is to help our clients achieve regulatory compliance, increase operational efficiency, and reduce the risk of non-compliance through effective ETMF management.
It is the primary responsibility of Project Management to maintain complete operational responsibility for each project throughout its lifecycle at SterlingBio. The primary tools by which this is accomplished are superior communication and organizational skills. These skill sets are among the core competencies of each project manager at SterlingBio.
The key responsibilities of project managers are:
- Selection of investigators for each study and recruitment of investigators as necessary
Organization and facilitation of Investigators Meeting
Serve as SterlingBio’s Project Team Leader
Function as SterlingBio’s primary contact with the Sponsor and investigational sites, sharing information at regular intervals with the Sponsor
Design and implement subject recruitment strategies
Coordination and oversight of all study-related activities with the sponsor, the study sites, and with all operational and consultative departments within SterlingBio
Responsibility for fiscal management of the project budget on behalf of SterlingBio and the sponsor
Our contracting solutions group provides temporary and permanent staffing solutions to the BioPharma industry. With depth and experience in the clinical trials area, you can be assured that we will provide you with the right person for the job.
- Temporary or Permanent clincial research staffing to fill staff shortages
- Expertise inclides medical monitors, management, clinical research associates, development, and staff
- Clinical research staff recruiting, screening, interviewing and extensive reference checking
SterlingBio maintains a regionally-based monitoring force comprised of Clinical Research Associates, Senior Clinical Research Associates and Associate Directors of Field Operations dispersed geographically in those regions in which we operate. Monitors receive continuing education throughout each project, maintain an excellent, cooperative working relationship with other departments within the company, and have extraordinarily low turnover. Chief among the monitors’ responsibilities are
- Adherence to protocol-specific monitoring guidelines
- Assurance of compliance to protocol and GCPs
- Regular review of study binders
- Case Report Form review and retrieval
- Study medication tracking and accountability
- Adverse experience identification and follow-up
Regulatory Document Management
In their efforts to develop new drugs and medical technologies, BioPharma firms face increasingly greater mountains of paper documents that slow the drug development process. Inefficiencies due to manual document handling raise development costs and slow team collaboration and responsiveness.
SterlingBio regulatory document management consulting practice can help you reduce the paperwork mountain, helping you to transform manual document management processes into digitized web-based knowledge that helps your clinical trials run smoothly and more efficiently. Some of the Regulatory Document Consulting Services we offer include
- Electronic Trial Master File consulting – eTMF
- eTMF Analysis and Design
- eTMF Taxonomy and Metadata development
- eTMF Taxonomy delivery in database, XML and other electronic formats for use in content management systems like Alfresco Documentum, IBM, Nuxeo, Oracle and others.
SterlingBio is actively engaged in the leadership and development of standards based taxonomies and metadata for clinical trials. Contact us today for more information regarding our regulatory document consulting services.
SterlingBio works with an extensive network of Quality Assurance partners to deliver in all geographic regions and in synergy with all client functional areas. SterlingBio’s Quality Assurance services include:
On-site investigator audits
GCP, GLP, GMP guidance
Database audits and official file audits
Computer validation and system audits
Clinical laboratory audits
Clinical study report audits
GCP compliance review
Each member of SterlingBio’s Medical Writing group has the professional experience, scientific knowledge and regulatory expertise to produce clear and concise reports targeted to the specific requirements of US, Canadian and European regulatory agencies. All reports are prepared according to the Sponsor’s specifications and in strict accordance with prevailing guidelines and regulations. Submissions and related documents produced by SterlingBio’s Medical Writing Group include:
Study protocols and amendments
Investigator drug brochures
Final study reports
Integrated summaries of safety
Integrated summaries of efficacy
IND, NDA, PLA, MAA and analogous submissions
Clinical Trial Technology Services
SterlingBio’s BioPharma Technology Services Group provides our sponsors with a range of computer software and systems technology consulting services:
Clinical Trial Software Needs Assessment and Evaluations
Clinical Trial Process Automation Consulting
Study Information Integration and Exchange
Mobile computing technology solution design
Interactive Voice Response Telephony solutions
Automated clinical trial software and systems increasingly permeate the BioPharma industry, requiring knowledge of both clinical research business practices as well as computer software and systems. Let SterlingBio’s domain experts in Clinical Trials and Technology assist you today.