Falsification of data and the incoming collapse of the pharmaceutical industry
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My name is Kico Aizaki.
17th October, in 2023.
The Ministry of Health and Labor and Welfare announced that the SMO (Site Management Organization) had falsified number of 123 falsified dates on 25 cases of approval pharmaceuticals and medical equipment.
These was reported as accusation to The Ministry of Health and Labor and Welfare.
It has surprised me and felt such a big mystery.
I think that it is difficult to hide or falsification of dates by just only CRC (=clinical research coordinator) or SMO (Site Management Organization) for 10 years.
Because I have been working as a CRC for 18 years at the field (-hospital)
And my previous job was a nurse. I was working as a nurse in academic Medical University hospital and Cancer Center for 18 years.
And as a CRC, I have had my actual result or achievements consultation or management of 228 cases of subjects in 18 years And I started off my business including SMO in 2012 by myself.
I had managed and consulted 6 studies and consultation about more 60cases of subject as a CRC since I start off in 2012.
I have a deep knowledge of the medical field.
So, in these 10 years of clinical trials, I have felt suspicion towards 123 falsified dates.
In fact, there are going trial studies in the field (=hospital or clinic)
Many medical staff who are PI (=Principal Investigator), doctors, nurses, subjects, CRC, and co-medical conduct and takes part in each of duty in trial study.
I think that it is difficult to hide or falsify by only just the CRC or SMO in the last 10 years.
Because the clinical trial is overseen or watched by a Monitor who is associated with the pharmaceutical company (=CRO: Clinical Research Organization) by SDV (=Source Date Verification).
In Addition, in fact,
A CRO sometimes names or designates on to SMO to a trail study or the SMO is a subsidiary of the CRO.
And a CRO is associated with a sponsor (=Pharmaceutical Company).
Some companies are connected, this is the way it has been done by pharmaceuticals for 20 years.
So, there is a possibility to create unfairness by friendly relationship among them on trial studies.
I have been concerned that these relationships affect the validity of trial studies.
For example, overlooking of injustice or wrong doing of process in trial study’s protocol.
In fact, in regard to SDV (=Source Date Verification).
Recently, SDV is sometimes held by remote monitoring since the Corona Pandemic began.
But The Monitor never visits the Site (=Hospital or Clinic).
The Monitor has to oversee any trial-related duty and function under law of GCP (=Good Clinical Practice) under contract by the sponsor and CRO.
And if needed,
The Monitor has to give advice to the Site or CRC or PI (=Principal Investigator) under the law of protocol or procedure of GCP.
The Monitor has to maintain the quality of study, trial on behalf of a Sponsor.
The excerpt from GCP, Guideline Good Clinical Practice, sea below ↓
5. SPONSOR
5.1 Quality Assurance and Quality Control
5.2 Contract Research Organization (CRO)
5.2.1 A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
5.2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.
5.2.3 Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
5.2.4 All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial related duties and functions of a sponsor.
They (=CRO, Sponsor) wants a successful in which they collect date under the law of protocol, GCP from registered subjects.
But this situation (=falsified number of 123 falsified dates on 25 cases of approval pharmaceuticals and medical equipment.) is very strange.
For example,
CRC hid deviation of temperature of investigational medicinal product and procedure and operation.
Usually, the investigational medicinal product is monitored by checked monitoring in 24hour by a digital thermometer. (=the temperature logger)
.
And Monitor forcibly asked to submit of record of temperature logger every month.
If there has been a deviation of temperature during investigational medicinal product stored in 24hours.
In addition,
CRC or delegated medical staff would set the range of proper temperature by procedure of the investigational medicinal product which provided from Sponsor (= Pharmaceutical Company) to the site.
Hou did the CRC hide deviation of temperature?
Who had not checked the 24hours monitoring thermometer?
In My opinion that should not administrated investigational medicinal product under not compliance the low of procedure of investigational medicinal product but also could not prescribe to subjects on trial study.
then it should not effectiveness of medication in clinical trial.
This event which seems like a destruction of established of essence and basis is not a trial.
How could 123 falsified dates on 25 cases of approval pharmaceuticals and medical equipment for10 year be hidden?
I don’t want to say there has been corruption between SMO and who?
Is there very friendly relationship between them?
Trials study should be done strictly for subjects and patient in future.
I Say again,
It is difficult to hide and falsify number of 123 dates on 25 cases of approval pharmaceuticals and medical equipment for 10 years by just only the SMO.
And then.
Finally. The Sponsor (=pharmaceutical) and CRO (=Associate with Pharmaceutical) had decided a Site (=Hospital or Clinic) and SMO (=Site Management Organization).
It is a very huge mystery!
And today, I got disappointing news.
The Major Generic Company apologized and announced that had has accusation of manufacturing process for 8 years in the past.
This company had collected by itself relevant to these drags which was not compliant to the manufacturing process.
I hear the big sounds of the pharmaceutical industry collapsing.
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