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Precision ISS & ISE Services: Simplifying the Complex

Submission expertise delivered, at the speed of Precision.

At Precision for Medicine, excelling in complex submissions is more than our history—it's our promise. Our ISS & ISE solutions are crafted for strategic inquiry, robust integration, and precise execution. Entrust your complex submissions to our capable hands, and experience a smoother, more assured journey towards submission readiness.

Precision integration of safety and efficacy summaries

The Integrated Summaries of Safety and Efficacy (ISS & ISE) form the cornerstone of your New Drug Application (NDA), serving as a critical factor in the regulatory review process. A meticulously planned and executed ISS & ISE not only streamlines regulatory approval but also minimizes queries from health authorities. At Precision for Medicine, we harness decades of cross-therapeutic expertise, covering a vast array of designations and regulatory pathways, to empower your submissions. By partnering with us, you’ll benefit from our comprehensive approach to navigating the intricate processes of ISS & ISE, ensuring your data tells a compelling, coherent story that meets stringent regulatory standards.
  • Plan for Optimal Outcomes
  • Data Synthesis & Analysis
  • Holistic Support

  • Maximizing Efficiency in Critical Timelines

    Initiating ISS & ISE at the right moment is pivotal. Our strategic guidance in ISS & ISE commences early, syncing with your phase III activities to forecast and mitigate risks efficiently. This proactive approach ensures timely market access by streamlining submission timelines and facilitating smooth regulatory navigation.
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  • Expert Integration for Comprehensive Insights

    The complexity of amalgamating data from various phases, including legacy studies, demands an adept and thoughtful strategy. Precision’s seasoned data management and biostatistics teams employ advanced analytical techniques, ensuring your safety and efficacy data are integrated seamlessly to support conclusive regulatory outcomes.
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  • Collaborative Excellence for Submission Success

    Our ISS & ISE services are enriched by Precision’s collaborative spirit, bringing together expertise from clinical operations, regulatory affairs, biostatistics, statistical programming, and medical writing. This multidisciplinary approach guarantees a unified and strategic submission process, from pre-submission strategy meetings to addressing post-submission queries, ensuring a coherent and persuasive presentation of your data.
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Quantifying success: Precision's global ISS & ISE expertise

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Expert programmers worldwide Our statistical programmers, globally distributed and diverse, bring extensive experience to every data analysis challenge, ensuring top-tier performance and precision.
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ISS & ISE submissions completed Precision has navigated the complexities of ISS & ISE submissions for a variety of drugs, delivering comprehensive, strategic reviews either combined or as standalone analyses.
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Regulatory agencies engaged Our ISS & ISE submissions have met the rigorous standards of the FDA, EMA, Health Canada, and PMDA, testifying to our broad regulatory expertise and deep understanding of international submission requirements.
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MetaVate: Transforming ISS & ISE data integration

Unlock the transformative potential of clinical data with MetaVate, Precision’s cutting-edge technology. MetaVate revolutionizes the data landscape for Integrated Summaries of Safety and Efficacy, facilitating seamless integration and alignment critical for these pivotal submissions. This platform goes beyond mere data transformation; it excavates deep insights that bring unmatched clarity and precision to your ISS & ISE documentation.

MetaVate excels in unifying diverse studies and data structures, streamlining even the most complex Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE). Its automation is metadata-driven, compliant with CDISC standards, enabling swift conversion of any clinical data source to regulatory-required formats like SDTM and ADaM. With MetaVate, transform voluminous legacy data into cohesive, submission-ready narratives, enhancing the speed and efficacy of your regulatory journey.

Read our latest Precision insights

Dive into the latest insights and breakthroughs from Precision's ISS/ISE submissions, alongside a wealth of knowledge spanning the spectrum of global clinical development.

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Read: Case Study: An Advanced Approach to Integrated Summary of Safety Studies Case Study

Clinical Trials - Regulatory

Case Study: An Advanced Approach to Integrated Summary of Safety Studies

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778876, hs_child_table_id=0, hs_updated_at=1709645745107, hs_published_at=1736962071401, description=Michelle Clark, Ph.D. is a Senior Lead Biostatistician. She received her Ph.D. in Biostatistics from UCLA and has more than 12 years of combined research experience in academic, hospital, and CRO settings. As both lead statistician and statistical oversight, Michelle has successfully supported Phase I-III clinical trials across a broad range of therapeutic areas including oncology, genetic disorders, and rare disease., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/michelle-clark.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/michellemarieclark, hs_name=, hs_path=, lastname=Clark, hs_initial_published_at=1716212769184, hs_created_at=1709645745107, hs_is_edited=false, hs_deleted_at=0, name=Michelle, job=, slug=michelle-clark, email=, hs_updated_by_user_id=26433386}, second={hs_id=159488778893, hs_child_table_id=0, hs_updated_at=1709645745124, hs_published_at=1736962071401, description=Veronica Ruvolo is a Senior Manager of Biostatistics with more than 7 years of experience covering a range of therapeutic areas, including strong experience in oncology that spans various clinical phases. She has successfully led and supported projects, including department initiatives, and is knowledgeable and practiced in statistical analysis and statistical programming ., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/veronica-ruvolo.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/veronica-wessel-ruvolo-0abba179, hs_name=, hs_path=, lastname=Ruvolo, hs_initial_published_at=1716212769184, hs_created_at=1709645745124, hs_is_edited=false, hs_deleted_at=0, name=Veronica, job=, slug=veronica-ruvolo, email=, hs_updated_by_user_id=26433386}, third={}})
  • Michelle C. avatar

    Michelle C.
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    Veronica R.
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Read: Increased Complexity and Therapeutic Combinations Pave the Way in Immuno-oncology Increased Complexity and Therapeutic Combinations Pave the Way in Immuno-oncology

Clinical Trials - Oncology

Increased Complexity and Therapeutic Combinations Pave the Way in Immuno-oncology

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778887, hs_child_table_id=0, hs_updated_at=1715690972359, hs_published_at=1736962071401, description=Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines., avatar=Image{width=720,height=829,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/AndyKinley_headshot.png',altText='AndyKinley_headshot',fileId=167369936018}, linkedin=https://www.linkedin.com/in/andy-kinley-phd-5759551, hs_name=, hs_path=, lastname=Kinley, hs_initial_published_at=1716212769184, hs_created_at=1709645745118, hs_is_edited=false, hs_deleted_at=0, name=Andy, job=, slug=andy-kinley, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
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    Andy Kinley
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Read: FDA Accelerated Approval for Oncology Therapeutics: Clinical Trial Considerations FDA

Clinical Trials - Regulatory - Oncology

FDA Accelerated Approval for Oncology Therapeutics: Clinical Trial Considerations

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1709645745115, hs_published_at=1736962071401, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1716136551646, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
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    Vann Parker
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