Clinical study suppliers (service providers) -- extent of control

#1
Hello. I'm struggling with assigning a risk classification to clinical study providers. For example, if a supplier helps us to manage clinical data or helps us maintain HIPAA compliance, what is the extent of control we should have over these suppliers? It is a compliance risk rather than a device quality risk/patient risk. How does everyone else manage these suppliers? Thanks.
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
There could certainly be a risk to patients - maybe not directly, but if they screw up the data, you could have invalid clinical data for safety or efficacy.

I treat them as pretty high risk. I want a Quality Agreement with them. (I had one client who didn't execute a quality agreement with them and didn't stipulate data ownership and, as a result, could not get the data collected, only summary reports!) I want to see any software used validated and I want to be sure they have the proper competencies in the type of clinical study to be conducted (as well as basic competencies in data integrity). And, as you note, data security is a huge concern. A breach there could cost you dearly so I want to see what those controls are (logical and physical - and for both the "live" data as well as backups).

I think there's a tendency to strictly adhere to risk-based buckets without flexibility to manage as the needs arise. Hopefully you have the flexibility to escalate the level of control irrespective of what bucket the supplier may fall in based on your criteria.
 

Ronen E

Problem Solver
Moderator
#4
There could certainly be a risk to patients - maybe not directly, but if they screw up the data, you could have invalid clinical data for safety or efficacy.
There's also the risk (to the patient) of breach of privacy.
 

Ronen E

Problem Solver
Moderator
#5
I'm struggling with assigning a risk classification to clinical study providers. [...] How does everyone else manage these suppliers?
At least under the MDR, clinical studies are a critical component in the compliance scheme, can vacuum huge resources, usually have long time-scales, can go awfully wrong and you'd know that only at/near the end... So, overall, it seems like a high-risk activity. But then, "clinical study providers" can be all sorts of entities, responsible for all sorts of elements, or the whole thing.

Generally speaking, by default I'd assign to "clinical study providers" the highest control level you have, yet I agree it's good to have a safety valve in your SOP to allow you to downgrade with a proper justification.
 
Thread starter Similar threads Forum Replies Date
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
Aymaneh Clinical study CE Marking (Conformité Européene) / CB Scheme 1
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Custom Medical Device For Clinical Study Other Medical Device Regulations World-Wide 1
Ajit Basrur How do I label this commercial product ready for clinical study? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S ITA (Investigational Testing Authorization) for Clinical Feasibility Study Canada Medical Device Regulations 4
B PMCF study plan is same to clinical investigation plan? EU Medical Device Regulations 3
M 510(K) submission for clinical study devices US Food and Drug Administration (FDA) 2
M Does Medical Device Usability Study = Clinical Trial? Other Medical Device and Orthopedic Related Topics 26
A Design Control Requirements: IDE exempt, NSR Device (Clinical Study) US Food and Drug Administration (FDA) 2
C IFU Language Requirements for FDA Clinical Study conducted in EU EU Medical Device Regulations 3
bio_subbu FDA issues draft PMA (Pre-Market Approval) Clinical Study Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D ETO Sterility Requirements for FIM Clinical Study in Europe Other Medical Device Regulations World-Wide 3
S Clinical Trial Study Reports - SOP Other US Medical Device Regulations 3
P QA requirements for non CE-Marked Device participating in a Clinical Study EU Medical Device Regulations 1
T US Clinical Study conducted in EU - What are EU Complaint handling reqts? EU Medical Device Regulations 4
N Clinical trials - Generic "parent" procedure vs. study-specific "child" versions Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
L Definition Bench Test - Definition (in FDA context) and its difference with Clinical Study? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
P Blinding Checks for labels in a clinical study US Food and Drug Administration (FDA) 5
N Unused proceses (Clinical Evaluation) ISO 13485:2016 - Medical Device Quality Management Systems 4
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
H MDR clinical evaluation EU Medical Device Regulations 0
I Brazil clinical data/trial requirement Other Medical Device Regulations World-Wide 0
S Impact to clinical evaluation of MDCG2022-14 EU Medical Device Regulations 2
R Clinical evaluation for instrument of a navigation system EU Medical Device Regulations 1
A Loss of certification because of outdated information in the Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 8
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
R MDR Clinical Evaluation Plan EU Medical Device Regulations 6
R Clinical Evaluation - state of the art literature search EU Medical Device Regulations 5
J Clinical Evaluation For Instruments - Class I, Class Ir, Class Im, and Class IIa - EU MDR EU Medical Device Regulations 4
M Clinical evaluation interface with the risk management process EU Medical Device Regulations 9
A Metadata For Drugs, API's, Regulatory & Clinical Documents and Dossier Service Industry Specific Topics 2
M Conducting a clinical investigation with clinical data from India EU Medical Device Regulations 3
V MDR – Article 65 – Clinical investigations on minors EU Medical Device Regulations 6
L Clinical Evaluation MDR EU Medical Device Regulations 15
B Clinical Investigation in Denmark for MDR EU Medical Device Regulations 2
S Exclusion of chapter 7.5 production for clinical investigation ISO 13485:2016 - Medical Device Quality Management Systems 1
K Clinical Studies of MD and IVD in the US US Food and Drug Administration (FDA) 6
A Post-market Clinical Follow-up Other Medical Device Related Standards 3
S IDCB 0129/0160 Clinical Risk Management ISO 14971 - Medical Device Risk Management 2
L Clinical investigation Medical Device and FDA Regulations and Standards News 0
I Clinical evaluation for legacy device EU Medical Device Regulations 16
M Clinical evaluation report training EU Medical Device Regulations 3
K Continue to do clinical evaluation? or transfer to RA? or focus on clinical studies as MA? Career and Occupation Discussions 1
K Do you have separate clinical risk management group or experts in your manufactures? EU Medical Device Regulations 4
B Mexico - Clinical Investigation in children Other Medical Device Regulations World-Wide 4
shimonv Device deficiencies (~complaint) discovered during a clinical trial ISO 13485:2016 - Medical Device Quality Management Systems 3
O CLINICAL EVALUATION - VACCUM PLANTS Other Medical Device Related Standards 4

Similar threads

Top Bottom