Understand your study evidence and data more clearly.
Therapeutics Data helps biotech teams analyze scientific evidence, study the clinical and competitive landscape, review study data and reports, and prepare scientific documentation.
You can start with a single question, a report, or a specific file. No need to roll out a platform or kick off a months-long project.
Defined projects. Clear deliverables. Scientific and analytical work reviewed by people.
Pick a source or an answer to see the detail.
Defined projects
Every engagement starts with a clear scope and deliverable, not an open-ended subscription.
Human review
Technology speeds up the work; a person reviews every analysis before it's delivered.
No platform to roll out
Start with a question, a report, or a file. No need to adopt a new system.
When evidence, data, and reports are scattered, keeping a clear view takes too much time.
A biotech company may need to review publications, understand what other programs are doing, prepare a clinical trial, interpret provider reports, and analyze new data deliveries — often at the same time.
Therapeutics Data takes concrete problems and turns them into defined engagements that add capacity without requiring the team to roll out a new platform or immediately grow its internal structure.
Scattered evidence
Publications, trials, and provider reports live in different places, and someone has to go through them one by one.
Manual review
The team ends up combining searches, files, and spreadsheets to answer questions that should be quick.
Little internal time
Researching, analyzing, and following up on all of it competes with the team's other scientific and clinical work.
Three areas where we can help your team.
Pick the area closest to the problem you have today. Every project is scoped before we start.
Evidence and competitive landscape
Understand what's known, what other teams are studying, and where questions remain open.
- Scientific evidence
- Trials and competitors
- Endpoints and biomarkers
Study preparation and oversight
Get a clearer read on the trial environment, its indicators, and the information you receive from providers.
- Feasibility and recruitment
- KPIs and study data
- CRO reporting
Also available as ongoing tracking.
View clinical study supportAnalysis and scientific documentation
Review data, analyze results, and prepare scientific documentation with a clear, traceable process.
- Data deliveries
- Preclinical data
- Scientific documentation
Each service's scope is defined with you before any data or document is shared.
You don't need to commission a big project to work with us.
Many engagements can start with a single question, a report, a set of publications, or a data delivery.
You share the topic you need researched.
- Relevant evidence
- Key studies
- Limitations
- Competitors and references
You share the indication or therapeutic area you're interested in.
- Active studies
- Competitors
- Phases and populations
- Relevant endpoints and trends
You share the document you just received.
- Key KPIs (key performance indicators)
- Changes
- Points worth flagging
- Questions for the next meeting
You share the file exactly as you received it.
- Structure check
- Duplicates
- Missing values
- Changes and possible inconsistencies
Clear indicators, transparent calculations.
Each KPI has a definition, a source, and a clear calculation rule so the team can understand what's changing and how to interpret the result.
Forms completed
Share of expected forms that are already complete.
Queries >14 days
Queries that have been open for more than 14 days.
Median lag
Typical time between a visit and its data entry.
Discrepancies
Records that should match between two sources but don't.
How are these indicators calculated?
Forms completed
The percentage of forms that should be available by a given date and are already complete.
Queries >14 days
data query: A data query is a formal question raised when a data point is missing, looks inconsistent, or needs clarification.
How many queries remain open more than 14 days after they were created.
If it exceeds 14 days, it's included in the indicator.
Median lag
How long it typically takes between a participant's visit and the corresponding data being entered.
We use the median because it better represents typical behavior when a few cases have extreme delays.
Discrepancies
Records that should match between two sources — for example, lab and clinical database — but show differences that need review.
From a dataset to a concrete question the team can review.
This example uses synthetic data — created purely for demonstration — and shows how we can summarize study KPIs, compare sites, review providers, and flag changes that need attention.
Sites with the most queries open >14 days
Absolute count and rate per 100 expected forms
Flagged for review = ≥10 queries open >14 days, or a high rate relative to the site's volume.
Open queries >14 days, 12-week trend
PRIORITY FINDINGS
Demo priorities represent data review priority, not medical severity.
How we interpret the indicators
Expected forms completed
- What it measures
- What percentage of the forms that should exist as of the data cut are already complete.
- How it's calculated
- Forms complete ÷ forms expected × 100, counting participants and visits that occurred up to the cut.
- Where it comes from
- The study's primary data capture system.
- How to interpret it
- A low value can indicate an entry lag, not necessarily a problem with the participant.
Open data queries >14 days
- What it measures
- How many data queries remain open more than 14 days after they were created.
- How it's calculated
- Queries where cutoff date minus creation date exceeds 14 days are counted.
- Where it comes from
- The data query log from the clinical system and from providers.
- How to interpret it
- A sustained increase often signals that a site or provider needs extra support resolving items.
Entry lag
- What it measures
- How long it typically takes between a visit and the corresponding data being entered.
- How it's calculated
- Median number of days between the visit date and the first recorded entry.
- Where it comes from
- Visit and entry dates from the clinical system.
- How to interpret it
- We use the median, not the average, because it better represents the site's typical behavior.
Cross-source discrepancy
- What it measures
- Differences between two sources that should match and don't.
- How it's calculated
- Records with open discrepancies ÷ records compared × 100.
- Where it comes from
- Comparison between the clinical system and an external source, such as the lab.
- How to interpret it
- It doesn't indicate which source is correct — only that there's a difference someone needs to review.
Rate per 100 forms evaluated
- What it measures
- A way to compare sites with different participant volumes.
- How it's calculated
- Queries open >14 days ÷ forms evaluated × 100.
- Where it comes from
- The same data used for the open-queries indicator.
- How to interpret it
- It lets you compare a small site with a large one without size distorting the comparison.
From indicator to a concrete question
Queries open for more than 14 days increased since the last cut. Is there a plan to bring this backlog down?
Typical data entry lag increased from 1.8 to 4.2 days. Was there an operational change that explains it?
Five records are still pending reconciliation with the clinical database. When are they expected to be resolved?
Reconcile: To reconcile means comparing two sources that should contain compatible information and resolving the differences.
A question can become a structured map of the evidence.
Question
What clinical evidence exists for a given therapeutic pathway in an indication?
What looks consistent
- Several studies agree on the size of the effect observed in the main population.
- The pathway shows a similar safety profile across the identified programs.
What remains uncertain
- It's unclear whether the effect holds in populations with relevant comorbidities.
- Long-term follow-up data is still limited.
Studies worth reviewing
- A Phase II trial with the design most comparable to your own program.
- A recent systematic review on the same therapeutic pathway.
The numbers and conclusions in this example are illustrative. They don't represent a real analysis or real companies.
From a concrete question to a useful deliverable.
You tell us what you need to solve
It can be a scientific question, a report, a protocol, or a data file.
We scope the work
We agree on what we'll analyze, what information we need, and what you'll receive.
We research and analyze
We combine scientific review, data analysis, and tools we've built in-house.
You get a result you can review
We deliver conclusions, supporting data, references, and the relevant limitations.
If the project requires specialized regulatory, statistical, or clinical expertise, we bring in the right professional.
Technology that helps us work faster, human review that delivers with judgment.
Technology
We use automation and artificial intelligence to speed up tasks like search, classification, document comparison, and data control.
Human review
Everything we deliver is reviewed before it reaches the client. Technology helps us work faster — it doesn't replace scientific judgment.
For biotech teams that need extra capacity at specific points in development.
Therapeutics Data can complement scientific, clinical, data, or development teams when they need to research a question, analyze information, prepare a study, or review documentation without taking on a technology transformation project.
Preclinical biotech
Evidence, competitors, data analysis, publications, and preparation for the transition into clinical development.
Teams preparing a clinical study
Clinical landscape, feasibility, recruitment, KPIs, data, and documentation.
Teams with trials underway
Report review, indicator tracking, delivery control, and provider analysis.
Analysis, documentation, and additional expertise when the project requires it.
We work with a defined scope and adapt the team to the type of project. We can handle scientific analysis, data, and documentation directly, and bring in specialists when a task needs specific expertise.
Scientific writing
We turn results, evidence, and analysis into clear, well-structured scientific materials for review, publication, or internal communication.
- Manuscripts
- Scientific abstracts
- Posters
- Literature reviews
- Scientific presentations
- Technical reports
Regulatory documentation support
We support the scientific and documentary parts of regulatory work through evidence search, synthesis, organization, and review.
- Evidence search and synthesis
- Scientific background
- Tables and summaries
- Consistency review
- Version comparison
- Drafting support
Specialists when the project requires them
Some tasks need specific expertise. In those cases, we can work alongside specialized professionals based on the project's scope.
- Regulatory affairs
- Biostatistics
- Clinical data management
- Clinical operations
- Pharmacovigilance
- Expertise in specific therapeutic areas
We work with a clear scope: Therapeutics Data does not replace a CRO (a contract research organization), the study medical team, or a specialized regulatory function. When a project requires that expertise, we involve appropriately qualified professionals.
Clinical research and development, explained clearly and practically.
We're building a practical library to help explain how clinical data and evidence are generated, reviewed, and used in biotech.
How to read a clinical trial
What to look at first when you review a published study's results.
What is a CRO
What a contract research organization does within a clinical trial.
What an endpoint actually means
What exactly the measure used to evaluate a study's outcome is.
How to read a study's monthly report
Which sections are worth reviewing first in a periodic study report.
What KPIs a small company should track
Which indicators matter most when the team and the budget are small.
What a data delivery is
What's involved in receiving and validating a new dataset from a provider.
How to evaluate scientific evidence
How to tell solid evidence apart from preliminary evidence.
Preclinical vs. clinical results
What changes between a result obtained in the lab and one obtained in people.
What people usually ask before getting started.
We work with biotech companies and teams that need one-off or ongoing support in scientific research, data analysis, clinical studies, or documentation. The size of the organization isn't a requirement.
No. We also work with preclinical companies or those preparing their first study.
No. A contract research organization, known as a CRO, helps carry out various activities within a clinical trial. Therapeutics Data focuses on scientific analysis, data, clinical intelligence, and documentation.
Yes, when it helps get work done more efficiently. Every analysis and document is reviewed before it's sent to the client.
Yes. Many projects are designed to start with a single question, a report, or a specific dataset.
Yes. Our work can complement the information you already receive from your CRO or other providers.
We can support research, analysis, and scientific writing related to regulatory documentation. When the work requires a specialized regulatory decision, we bring in professionals with specific expertise.