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WHITE PAPERS AND CASE STUDIES

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO. 

• Improving Patient Health And Safety

  Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.

• Solving The Silicone Challenge In Pre-Fillable Syringes

  Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• How To Run Successful Clinical Trials In Japan

  Read about why there is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. 

• Development Of A Non-Standard Protein Therapeutic

  Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.

• Medical Writing Support Relieves A Burdensome Review

  Unearth how medical writing and project management teams were able to streamline the development and review of a critical marketing application document.

• A Comprehensive Planning Approach For Cancer Antibody

  Discover how a clinical-stage biotech company was able to accelerate pathways for development and regulatory review of their first Phase 1 protocol for an immuno-oncology antibody.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• How To Manage A Drug Product In A Medical Device Environment

  Discover how ProPharma successfully ensured GMP and GDP compliance for a drug product within a medical device environment.

• Performance Of Protein A Resins For Different mAbs

  Review a Protein A resin solution assisting biotech companies who are working with and removing impurities from a wide variety of antibodies.