Mitotics® Molecular Oncology · Scientific Intelligence · Clinical Research

Kim Lockheimer, PhD, DFM

lab@mitotics.com

+1 888 498 8650

mitotics.com

Scientific Writing Services

Precision science.
Expertly written.
Publication-ready.

Mitotics delivers PhD-level scientific and medical writing for pharmaceutical and biotech organizations — from regulatory-grade clinical study reports to high-impact manuscripts and authoritative whitepapers. Every document is grounded in molecular science, aligned to current guidelines, and crafted to move your program forward.

PhD Lead Writer
DFM Functional Medicine
15+ Years Research
Onc. Core Specialty
ICH Guideline Trained
01

Core Writing Services

Sc.
Scientific & Medical Writing
Primary Service

Rigorous, peer-review–ready scientific content authored by a practicing molecular oncology specialist. We translate complex data into clear, compelling narratives for clinical, commercial, and medical affairs audiences.

  • Peer-reviewed journal manuscripts (ICMJE compliant)
  • Conference abstracts & poster presentations
  • Investigator brochures & patient narratives
  • Medical affairs slide decks & briefing documents
  • Disease state overviews & MOA summaries
  • Scientific newsletters & pipeline summaries
Cs.
Clinical Study Reports
Regulatory Documentation

ICH E3–compliant CSR writing with deep biostatistical fluency and oncology-specific expertise. We produce complete, submission-ready reports that meet FDA, EMA, and global regulatory standards.

  • Full CSR authoring (ICH E3 structure)
  • Patient narratives & individual subject data
  • Integrated summaries of efficacy & safety (ISE/ISS)
  • Clinical study protocols & protocol amendments
  • Clinical overview & synopsis sections
  • QC review of existing CSR documents
Wp.
Whitepapers & Literature Reviews
Thought Leadership

Deep-dive scientific whitepapers and systematic literature reviews that establish scientific credibility, support regulatory strategy, and communicate clinical value to KOLs, investors, and payers.

  • Scientific whitepapers (10–30 pages)
  • Systematic & narrative literature reviews
  • Evidence dossiers & value summaries
  • Competitive landscape scientific analyses
  • Pipeline positioning documents
  • Scientific backgrounders for investor relations
Dr. Not a Writing Mill

Every document is personally authored and reviewed by Kim Lockheimer, PhD, DFM — a practicing molecular oncology specialist, not a ghostwriter managing a pool of contractors.

Mol. Deep Science Fluency

Molecular oncology, cell cycle biology, biomarker science, and clinical pharmacology expertise embedded in every document — not paraphrased from your data alone.

Reg. Regulatory Literacy

ICH E3, E6, E8, and GCP-aligned writing. Familiarity with FDA and EMA submission requirements, GPP3 publication ethics, and CONSORT/STROBE guidelines.

Sp. Oncology Specialty

Core expertise in solid tumors, hematologic malignancies, targeted therapies, immuno-oncology, and ADCs — the highest-demand specialty in pharma writing today.

02

Retainer Packages

Mitotics operates on a monthly retainer model — ensuring your program has consistent, dedicated writing support without the unpredictability of per-project billing. Retainers secure priority access, dedicated bandwidth, and institutional familiarity with your pipeline, compound, and data.

Most Popular
Tier I
Essential
Emerging biotech · Early-stage programs
$3,500 / mo
Billed monthly · 3-month minimum
Up to 20 hrs / month
  • 1 primary document per month
  • Scientific or medical writing deliverables
  • 1 literature review per quarter
  • Up to 2 revision rounds per document
  • Email support within 48 hours
  • Rollover of up to 5 unused hours
Tier III
Enterprise
NDA/BLA programs · Large pharma
Custom rate
Scoped by program · Flexible structure
Dedicated bandwidth
  • Full submission package support
  • Dedicated primary writer assignment
  • ISE / ISS / Clinical Overview authoring
  • Cross-functional team integration
  • Custom SOW & milestone deliverables
  • 24h response SLA available
  • Regulatory strategy co-development
  • White-label / attribution-flexible options

Add-On Services · Available à la carte or with any retainer

ABS
Abstract Writing
Conference submission–ready abstracts. ASCO, AACR, ASH, ESMO–formatted.
From $650
QC
Document QC & Scientific Review
Expert review of existing documents for scientific accuracy, clarity, and regulatory alignment.
From $250 / document
SLR
Systematic Literature Review
PRISMA-compliant SLRs with protocol development, database search, and full synthesis.
From $3,200
GW
Grant Writing Support
NIH, NCI, DoD, and private foundation grant narrative development and scientific editing.
Custom scope
POD
Scientific Poster Design
Conference poster design with scientific content authoring — ready for print and digital.
From $850
EDU
Medical Education Content
CME-compliant disease state education, MOA narratives, and HCP training materials.
From $1,200
03

Engagement Process

I
Discovery

30-min confidential discovery call. We review your program, data package, target audience, and timeline.

II
Scope

We propose the appropriate retainer tier and document scope. NDA / MSA signed. Data securely transferred.

III
Strategy

Scientific strategy call. We review your data, define key messages, and align on publication or submission strategy.

IV
Authoring

First draft delivered per agreed timeline. Structured revision process with tracked changes and clear version control.

V
Delivery

Final submission-ready document delivered. Ongoing retainer provides continuous support for subsequent deliverables.

04

Scientific Credentials & Therapeutic Coverage

  • PhD — Molecular Oncology / Cell Biology
  • DFM — Doctor of Functional Medicine
  • Specialist in mitotic inhibitors, DNA repair, and drug resistance mechanisms
  • Trained in ICH E3/E6/E8, GCP, CONSORT, STROBE, PRISMA guidelines
  • Experience with FDA, EMA, and global regulatory submission formats
  • GPP3 (ISMPP) good publication practice adherence
  • Biomarker development, companion diagnostics, and precision oncology
  • NDA/BLA dossier experience across Phase I–IV programs
  • Peer-reviewed publications in molecular and clinical oncology
Therapeutic Area Coverage
  • Solid Tumors — Breast, Lung, CRC, Pancreatic, ProstateCore
  • Hematologic Malignancies — AML, DLBCL, MyelomaCore
  • Targeted Oncology — KRAS, EGFR, HER2, BRAF, RETCore
  • Immuno-Oncology — Checkpoint Inhibitors, CAR-T, BispecificsIO
  • ADC / Radioligand TherapyEmerging
  • Biomarker Science & Companion DiagnosticsCore
  • Precision Medicine & GenomicsGenomics
  • Hormone-Driven Cancers & EndocrinologySpecialty
  • Clinical Pharmacology & Drug MetabolismPK/PD