Contract Staffing

PharmaLogics Recruiting has recently acquired Orbis Clinical, a life science contract staffing and consulting firm covering all facets of Research and Development from pre-clinical to post-market. Orbis Clinical, a Division of PharmaLogics Recruiting, will allow us to expand and further service the needs of PharmaLogics and Orbis clients, covering the full gamut of life science functions in both permanent and temporary placement. For more information on the partnership, please see the press release.

We utilize one of the most extensive networks of professional contacts in the country to identify the most qualified short-term professional talent available. We can identify, recruit and place W2 or 1099 contractors on short-term assignments or temporary-to-permanent roles. We can also provide payroll and benefits to a candidate our clients have found independently.

We offer a variety of services for clients and consultants, which includes: Regulatory Affairs, Drug Safety, Quality Assurance, Medical Affairs, BioMetrics, Clinical Operations, Health Economics, and Scientific expertise.

Regulatory Affairs

We provide strategic and operational support to manage regulatory projects and initiatives. Our consultants are industry professionals who have the experience to manage entire portfolios, including pharmacy, devices, generics, over-the-counter, nutritionals and cosmetics.

Global Regulatory Strategy

Development & Implementation of Pre-IND/NDA, Clinical and Post-Market

Subject Matter Expertise

Regulatory Response, Rare Disease, Fast-Track, Orphan Drug, Rx-to-OTC switch

Operations & Submissions (eCTD/CTD formatting and publishing, Document management, archiving, Global Dossier and Technical File review), Labeling (Writing/review/approval of label content, CCDS development and review), Advertising & Promotion (Promotional Review, Product launch expertise), Medical Writing (Submissions (NDA, BLA, IB, IND, CSR, MAA, 510k, PADER, DSUR etc.), Non-Clinical/Clinical (posters, abstracts, slide decks)), CMC (Strategy/Operations/Writing

Drug Safety

We provide dedicated consultants within drug safety, pharmacovigilance and risk management to augment existing teams, outsource spikes in workload, or to bring an added level of subject matter expertise to your organization.

PV Operations (Case processing, Data entry, triaging, coding, narrative writing for clinical and post marketing, Medical coding/MedDRA, WHO Drug, Scientific Literature Review), Physician Level Support (Medical Case Review, Aggregate Data Review, Risk Mgmt. Development, Safety Signal Detection, Submission Writing) PV Information (Database SMEs (Clintrace, Argus, ARISg, RAVE), PV Compliance & Quality Assurance, PV Auditing)

Quality Assurance

We provide the quality assurance expertise to assist life sciences organizations with their highly regulated products. Our consultants provide world-class quality support across all facets of research and development, from pre-clinical to post-market.

Service Offerings:

Quality Assurance, Quality Control and Quality Systems Subject Matter Expertise (Remediation, Site Readiness Assurance, Batch Record Review, Document Control, ISO Compliance, CAPAs and Quality Management Plans, FDA 483 Response Preparation and Review, SOP Development and Review, Policy Development, Validation Guidelines, Validation Plans, Test Plans and Procedures, Project Management)

Auditing

Internal and external, domestic and international GxP auditing of: GMP (Manufacturing Facilities (API, Drug Product, Sterile Product), Manufacturing (Excipient/ Raw Material), Analytical Lab (Micro, Stability, Release), Clinical Packaging/Distribution), GCP / GLP / GCLP / GVP (CROs, Investigators, Monitors, Suppliers & Study Sites, Contract, QC, Central, Specialty & Analytical Laboratories, Safety Reporting / PV Audits / Software Vendor), Licensing Partners & Agreements

Medical Affairs

Our Medical Affairs division has experienced personnel who can educate department members, see that consumer questions are addressed, provide input and expertise in the design and construction of all promotional materials and events, and provide informational services to health care providers in the community. Our professionals provide regulatory reviews to ensure all written documents are accurate and adhere to the guidelines mandated by the FDA.

Services Include:

Medical Communication, Medical Writing, Medical Information, Medical Science Liaison, Physician Support, Product Strategy, Publication Planning

BioMetrics

Biostatistics

Our statisticians are intricately involved in study design, CRF design, data import/export and data cleaning and review and are often consulted to perform special calculations and summarizations of information for non-study related issues for problem solving and process improvement. Our SAS programmers perform statistical programming and data programming, as well as providing tables, figures and listings (TFLs) based on the analyses and format specified in the Statistical Analysis Plan.

Comprehensive Biostatistic Services: Input on sample sizes and analysis of endpoints, Detailed statistical analysis plans, TFL generation including required statistical analysis, Consultation on statistical topics

Clinical Data Management

We provide dedicated clinical data management consultants who know the importance of accurate and timely data management for your clinical trials.

Service Offerings

Study Setup (CRF design and development, Database build and testing, Edit Checks preparation and testing, Study Conduct), Data Entry (Discrepancy Management, Data Coding (MedDRA,WHODDE), SAE Reconciliation, Data Transfer) Study Closeout (SAE Reconciliation, Quality Control, Database Lock, Electronic Archival, Database Transfer)

Clinical Operations

At PharmaLogics Recruiting, we understand your industry is constantly changing as breakthroughs in technology and science lead to new pharmaceutical discoveries. We support the evolving clinical research industries by providing flexible staffing solutions to grow, develop, and manage your clinical trials.

Services:

Strategic development and maintenance of clinical trials from protocol development to study close out, Operational support to handle small and large scale clinical trials, Develop, implement, monitor, and support SOPs and work processes, Investigator site management, Deliver and maintain high quality data to support clinical trials, Establish and maintain Trial Master Files in accordance with regulatory and ICH guidelines

Health Economics & Outcomes Research (HEOR)

The goal off our consultants is to assist decision makers in acquiring the necessary information regarding the risks, benefits, costs, and acceptance of their products in order to make informed decisions about how to position those products in the marketplace.

Service Offerings:

Epidemiologic Studies, Cost, quality and outcome management, Effects of health insurance product design, Analysis of healthcare policies and regulations, Regulatory cost-benefit and impact analysis, Reimbursement, optimal pricing and utilization studies, Cost minimization, cost effectiveness, cost benefit, and cost utility studies, Value-based pricing, Economic assessments, Clinical trial outcomes data collection and management, Project management, Analysis and modeling of clinical trial data

Scientific

We provide dedicated scientific professionals to our life science partners to augment existing teams, outsource spikes in workload, or to bring an added level of subject matter expertise to your organization.

Biochemists/Chemists/Microbiologists/Pharmacologists, Cytotechnologists/Histotechnologists, Quality Assurance/Quality Control Professionals, Clinical Laboratory Scientists, Serious Adverse Effects Coordinators, Chief Scientific Officers, Scientists/Production Scientists, Pharmaceutical, Lab Assistants/Lab Technicians, Specimen Processors

To learn more, please contact us at 781.569.0607 and info@orbisclinical.com!