FUNCTIONAL AREAS

We provide three main services that support the drug development process. We offer our clients flexibility, the ability to scale efficiently, and skilled, experienced resources to get the job done.

BIOSTATISTICS • CLINICAL DEVELOPMENT • CLINICAL OPERATIONS • CMC DMPK/BIOA • MEDICAL AFFAIRS • MEDICAL WRITING • QUALITY AND COMPLIANCE • REGULATORY AFFAIRS • SAFETY & PHARMACOVIGILANCE

Individual Resources

Engage individual consultants or contractors to perform a specific task or fill a personnel gap

Functional Outsourcing

Organize an entire functional group comprised of contractors and consultants, enabling clients to operate lean and at scale

Fully Integrated Teams

Curate multi-functional, comprehensive tactical teams tailored to the specific needs of our clients

FUNCTIONS WE SUPPORT
IN THE UNIVERSAL
DRUG DEVELOPMENT PROCESS

IND ENABLING/ PRE-CLINICAL

  • Translational Medicine
  • Biomarker Identification
  • Regulatory Strategy
  • Pharmacology & PK/PD Modeling
  • Toxicology
  • Program Management
  • Scientific Report Writing

PHASE 1 (SAFETY)

  • Dosing – SAD/MAD and more
  • IND/CTA Planning and Filing
  • Risk Management Plan (RMP)
  • Trial Design
  • Clinical Operations
  • CRO Selection and Evaluation
  • CMC/Drug Product
  • Informed Consent Form (ICF)

PHASE 2/3 (EFFICACY)

  • Endpoint Development
  • Statistical Analysis Plan (SAP)
  • Supply Chain/Scale-up
  • KOL/Patient Advocacy Engagement
  • Medical Affairs Strategy
  • Pre-Approval Inspections (PAI)
  • Regulatory Submissions (NDA/BLA/MAA and More)
  • Clinical Project Management & Study Monitoring
  • Site/Vendor Selection and Evaluation

PHASE 4 (COMMERCIAL/ REAL WORLD EVIDENCE)

  • Ad/Promo
  • Labeling
  • Phase IV Project Management
  • Safety Updates/Monitoring
  • New Indications/Label Expansion

Case Study 1
Individual Resources >>
Case Study 2
Functional Outsourcing >>
Case Study 3
Tactical Teams >>

CASE STUDY 1
Individual Resources

The Need
A gene therapy client requested someone to act as Head of Translational Medicine. They needed to use biomarker data to substitute for secondary endpoints, and needed someone skilled in biomarker strategy, assay development and study design.

TCG Solution
We provided them with a consultant who had acted as head of translational sciences and VP of analytical sciences in his previous two roles, and whose doctoral dissertation was about using similar technology to treat the same class of diseases. Given the area of study, it was an incredibly niche request, and Conjugate Group delivered.

CASE STUDY 2
Functional Outsourcing

The Need
An oncology client had been granted fast-track review for their NDA for a new kinase inhibitor to treat GI cancers. The FDA requested a rolling NDA (one of the first of its kind) and document production would be a massive undertaking – and the client had very little medical writing staff in-house.

TCG Solution
We acted as a Functional Service Provider for their Medical Writing department throughout the NDA process. At its peak we had 13 dedicated writers – a Medical Writing SME, NDA Project Manager, several Principal Writers, several supporting writers, a team dedicated to Patient Narratives (there were 150) and a QC/Editing team. We produced and edited all clinical documents for the submission, delivered on time, and the drug was ultimately approved as the client’s first marketed product.

CASE STUDY 3
Tactical Teams

The Need
An immunotherapy client developing novel antibodies was planning for their first IND submission, but the core team was very small and only the CMO had submissions experience in the past. They needed a full team of SME’s and operational resources to both plan for and pull together the full submission.

TCG Solution
We provided Subject Matter Experts, consultants, and supporting team members. Our team consisted of an Operational and Clinical SME, CMC consultant, QA consultant, DMPK SME, Medical Writers, Biostatistician, and a Toxicology consultant. We also provided project management support and software. The IND was filed on time and accepted by the agency, and we have been asked to help submit two more.