OUR SERVICES

Through independent consultants (freelancers), Pharmalancers provides a range of services supporting the R&D and Commercial functions of biopharmaceutical companies. 

Our independent consultants undertake a large variety of projects. Examples include:

  • Taking sole responsibility for specific projects in biotechs and smaller companies

  • Supporting functional project teams in large and mid-sized pharma companies and CROs

  • Providing advice as SMEs to development and commercialisation programs in all types of biopharmaceutical companies

  • Providing flexible resourcing to individual functions in times of extra demand

All our independent consultants are screened and vetted before they become members of the Pharmalancers platform. One less thing for you to worry about!

CLINICAL PROJECT MANAGEMENT

We have freelance Clinical Project Managers (CPMs), based in a number of geographies,  with a wide range of experience across all phases of studies. Our CPMs can manage both internal study teams or CRO teams. For smaller companies and biotechs, our CPMs can also help form a full study team based on the client requirements.

In addition to overall study management, the CPM services include:  

  • Project Planning

  • Project Set-up / Execution / Close-out

  • Stakeholder Management

  • Budget Management

  • CRO/ Vendor Management

  • Risk Management

  • Global/ Regional/ In-country Studies

CLINICAL RESEARCH ASSOCIATE

Our global team of freelance Clinical Research Associates (CRAs) can perform most functions relating to study monitoring and site management. The CRA services include:

  • Phase I - IV Studies

  • Observational/ IIS Studies

  • Site Selection

  • Site Initiation / Management / Close-out

  • Site Training

  • Site Contracts

  • Budget Management

  • In-country Ethics and Regulatory knowledge

  • Unblinded Monitoring

Managed Clinical Services: Pharmalancers offers a range of managed service packages where we can assemble and manage a team of CPM(s), CRAs and other functional specialists in flexible, contractual models for the conduct of clinical trials.

MEDICAL WRITING (CLINICAL / REGULATORY)

Pharmalancers’ highly skilled and experienced medical writers can author or support the authoring of a broad range of clinical and regulatory document types in many therapeutic areas including:

  • Clinical Study Reports

  • Clinical Trial documents (Protocol, IB, ICF)

  • CTD Overview/Summaries

  • AE Narratives

  • PV Reports 

  • Patient Lay Summaries

  • Product Information Leaflets

MEDICAL / SCIENTIFIC COMMUNICATIONS

Pharmalancers’ Medical Writing service also includes a number of experienced medical/ scientific communications specialists providing expert authoring, editing and review services in:

  • Literature Review

  • Publication Planning

  • Manuscripts and Abstracts for Publications 

  • Congress and Symposia Materials

  • Medical Information Content

  • Standard Operating Procedures (SOPs)

  • Visual Abstracts

REGULATORY AFFAIRS

Through our Regulatory independent consultants, Pharmalancers can support a range of regulatory activities. 

For biotechs and smaller companies our experienced consultants can support regulatory strategy and help with all submissions and interactions with regulatory agencies. 

For larger and mid-sized pharma companies, in addition to advisory services, our consultants can also provide flexible operational resourcing in times of extra workload. 

Our services include:

  • Regulatory Strategy

  • Scientific Advice & Agency Meetings

  • Major Submissions (Marketing Authorisation, Clinical Trial Authorisation)

  • Post-Authorisation Submissions – Renewals/ Variations; SmPCs & Labelling; Safety Reports

  • Regulatory CMC Compliance

  • Dossier building & Publishing

  • Health Agency Interactions

PHARMACOVIGILANCE / SAFETY

Through our Pharmacovigilance (PV) independent consultants, Pharmalancers can support a wide range of PV activities of a biopharmaceutical company through the entire product life cycle. 

Our services include:

  • Case Processing Support*

  • Case Medical Review

  • Preparation and Submission of Aggregate PV Reports

  • Literature Review, Search and Management

  • EU QPPV Services 

  • PV Quality Assurance Services

  • Risk Management Plan (RMP)

  • Risk Evaluation and Mitigation Strategy (REMS)

*For dedicated case processing support on an ongoing basis, we can set-up clients with suitable service providers.

BIOSTATISTICS

Experienced biostatisticians are difficult to find. Pharmalancers can help you find experienced independent biostatisticians with experience in specific therapeutic areas to provide support to:

  • Study Set-up - Protocol Design, Randomisation, Sample Size

  • Statistical Analysis Plan

  • Study Analysis (TFLs - Tables, Figures and Listings)

  • Analysis Datasets

  • Statistical Reports

  • Data Safety Monitoring Board Representation

  • ISS/ ISE (Integrated Summaries of Safety and Efficacy)

  • CDISC Standards

STATISTICAL PROGRAMMING

Pharmalancers network of independent consultants also includes Statistical Programmers with experience of working with internal client teams and with independent biostatisticians in:

  • CDISC Compliant Data Analysis and Presentation

  • Statistical Programming - SAS

  • Statistical Programming - Others

  • Data Integration

  • ISS/ ISE (Integrated Summaries of Safety and Efficacy)

CLINICAL DATA MANAGEMENT

Pharmalancers can provide advice and support to some areas of Clinical Data Management:

  • Database Design

  • Data Input/Validation

  • Medical Coding

  • Vendor Selection and Management

QUALITY

Our independent consultants in Quality Management cover R&D, Manufacturing and Supply Chain. Services include:

  • Set-up / Management of Quality Management System (QMS)

  • Selection, validation and deployment of QMS Software

  • Quality Planning

  • Standard Operating Procedures (SOPs) and Gap Analysis

  • Audit – Good Manufacturing Practice (GMP),

  • Audit – Good Clinical Practice (GCP)

  • Audit – Good Laboratory Practice (GLP)

  • Audit – Good Pharmacovigilance Practice (GPvP / GVP)

  • Corrective Action Preventive Action (CAPA)

  • Risk Management

  • Inspection Readiness

  • Change Control

  • Continuous Improvement

  • Training

  • Strategic Quality Advice

PROJECT MANAGEMENT

We have a number of Project managers specialising in the pharmaceutical industry who can manage projects in the following areas:

  • R&D - Clinical Development, Discovery/ Pre-Clinical, Licensing Deals

  • R&D/ Commercial – Product Launch, Post-approval Drug Expansion

  • Commercial – Market Expansion/ Country Roll-out

  • Manufacturing Platform Scale-up, Site Changes

  • Business Transformation Programs

  • Operating Model – IT Systems Selection/Roll-out, Post-M&A Integration, PMO