Built for one kind
of trial.
Built for one kind
of trial.
Hematology and oncology, and nothing else. Six services that cover a study from feasibility to the final posted record, run by people who work in this therapeutic area every day. A full-service CRO sends a general team. We send the same specialists each time.
HEMATOLOGY AND ONCOLOGY ONLY · SIX SERVICES · 24-HOUR RESPONSE
HEMATOLOGY AND ONCOLOGY ONLY · SIX SERVICES · 24-HOUR RESPONSE
SERVICES
SERVICES
What we do. Nothing we don’t.
What we do. Nothing we don’t.
What we do. Nothing we don’t.
What we do. Nothing we don’t.
A full-service CRO lists everything it could do. This is what a hematology and oncology study needs, carried by people who do nothing else.
A full-service CRO lists everything it could do. This is what a hematology and oncology study needs, carried by people who do nothing else.
01
01
Clinical Research Finance
Clinical Research Finance
Clinical Research Finance
Medicare coverage analysis, billing grids, sponsor budget analysis, CTA and SOW review, CTMS study build and amendment impact.
Medicare coverage analysis, billing grids, sponsor budget analysis, CTA and SOW review, CTMS study build and amendment impact.
Medicare coverage analysis, billing grids, sponsor budget analysis, CTA and SOW review, CTMS study build and amendment impact.
EXPLORE ⟶
EXPLORE ⟶
02
02
Regulatory Disclosure
Regulatory Disclosure
Regulatory Disclosure
ClinicalTrials.gov registration, results reporting, QC comment remediation, portfolio assessment and backlog remediation.
ClinicalTrials.gov registration, results reporting, QC comment remediation, portfolio assessment and backlog remediation.
ClinicalTrials.gov registration, results reporting, QC comment remediation, portfolio assessment and backlog remediation.
EXPLORE ⟶
EXPLORE ⟶
03
03
Trial Operations & Site Management
Trial Operations & Site Management
Trial Operations & Site Management
Visit coordination, subject tracking, deviation and SAE tracking, delegation logs, and specimen logistics end to end.
Visit coordination, subject tracking, deviation and SAE tracking, delegation logs, and specimen logistics end to end.
Visit coordination, subject tracking, deviation and SAE tracking, delegation logs, and specimen logistics end to end.
DISCUSS ⟶
DISCUSS ⟶
04
04
Patient Recruitment & Retention
Patient Recruitment & Retention
Patient Recruitment & Retention
Screening and eligibility, consent coordination, recruitment strategy, enrollment tracking, retention programs and stipends.
Screening and eligibility, consent coordination, recruitment strategy, enrollment tracking, retention programs and stipends.
Screening and eligibility, consent coordination, recruitment strategy, enrollment tracking, retention programs and stipends.
DISCUSS ⟶
DISCUSS ⟶
05
05
Study Start-Up & Documentation Support
Study Start-Up & Documentation Support
Study Start-Up & Documentation Support
Feasibility, site selection, calendar mapping, essential documents, monitoring preparation and response, CAPA and training.
Feasibility, site selection, calendar mapping, essential documents, monitoring preparation and response, CAPA and training.
Feasibility, site selection, calendar mapping, essential documents, monitoring preparation and response, CAPA and training.
DISCUSS ⟶
DISCUSS ⟶
06
06
Data Management & Integrity
Data Management & Integrity
Data Management & Integrity
EDC entry, CRF review, query and discrepancy resolution, ePRO support, lab value tracking and result reconciliation.
EDC entry, CRF review, query and discrepancy resolution, ePRO support, lab value tracking and result reconciliation.
EDC entry, CRF review, query and discrepancy resolution, ePRO support, lab value tracking and result reconciliation.
DISCUSS ⟶
DISCUSS ⟶
HOW EACH IS DELIVERED
HOW EACH IS DELIVERED
Remote
Remote
Performed from KARAMATA, inside your own systems. Nothing to adopt, validate or migrate.
Performed from KARAMATA, inside your own systems. Nothing to adopt, validate or migrate.
Remote with a site assistant
Remote with a site assistant
When the protocol needs someone physically at the site. Hematology and oncology sites only, by definition.
When the protocol needs someone physically at the site. Hematology and oncology sites only, by definition.
Decentralized and hybrid
Decentralized and hybrid
Remote delivery into DCT and hybrid designs: telemedicine visits, ePRO, digital consent, direct-to-patient shipment.
Remote delivery into DCT and hybrid designs: telemedicine visits, ePRO, digital consent, direct-to-patient shipment.
NOTHING ADAPTED. EVERYTHING NATIVE.
NOTHING ADAPTED. EVERYTHING NATIVE.
Multiple myeloma ≠ cardiology with different endpoints.
Multiple myeloma ≠ cardiology with different endpoints.
Multiple myeloma ≠ cardiology with different endpoints.
Multiple myeloma ≠ cardiology with different endpoints.
Response criteria, CTCAE grading, expansion cohorts, survival follow-up that outlasts the budget. Every service on this page was built inside those constraints, not adapted to them afterwards. At a full-service CRO your study is one therapeutic area among twenty. Here it is the only one.
Response criteria, CTCAE grading, expansion cohorts, survival follow-up that outlasts the budget. Every service on this page was built inside those constraints, not adapted to them afterwards. At a full-service CRO your study is one therapeutic area among twenty. Here it is the only one.
HOW IT STARTS
HOW IT STARTS
Three steps, then a named specialist.
Three steps, then a named specialist.
Three steps, then a named specialist.
Three steps, then a named specialist.
No sales desk. No deck. A hematology and oncology specialist reads what you send and answers it.
No sales desk. No deck. A hematology and oncology specialist reads what you send and answers it.
01
01
Send the question, and whatever exists today.
Send the question, and whatever exists today.
A protocol, a budget, a stalled record. Missing pieces are a finding, not a problem.
A protocol, a budget, a stalled record. Missing pieces are a finding, not a problem.
01
Send the question, and whatever exists today.
A protocol, a budget, a stalled record. Missing pieces are a finding, not a problem.
02
02
A specialist replies within a day.
A specialist replies within a day.
With a first read, the service it belongs to, and the inputs we would need.
With a first read, the service it belongs to, and the inputs we would need.
03
03
Scope, owner and outputs are written down.
Scope, owner and outputs are written down.
Before any work starts, you know what you are buying and what you will hold at the end.
Before any work starts, you know what you are buying and what you will hold at the end.
WHAT WE DO NOT DO
WHAT WE DO NOT DO
We do not monitor, write regulatory submissions, run biostatistics or pharmacovigilance, or make applicable-clinical-trial determinations. If your study needs one of those, we say so on the first call and stay in our lane.
We do not monitor, write regulatory submissions, run biostatistics or pharmacovigilance, or make applicable-clinical-trial determinations. If your study needs one of those, we say so on the first call and stay in our lane.
Tell us where the study is.
Tell us where the study is.
Tell us where the study is.
We’ll place it in the right service and come back with a first step.
We’ll place it in the right service and come back with a first step.
OPERATIONS@KARAMATACLINICAL.COM · (888) 407-5682
OPERATIONS@KARAMATACLINICAL.COM · (888) 407-5682