Archive for the ‘Clinical Examinations’ Category

Bridging Studies – Company Culture and Structure of a CRO for conducting Bridging Studies

Monday, October 28th, 2013

The merits of a CRO (Clinical or Contract Research Organisation) with regards to subject retention and recruitment should be evaluated with at least similar attention and care as is given to a CRO’s ability to conduct a bridging study clinically and produce good quality viable data. When selecting a CRO or recruitment specialist to recruit specialist subject populations such as Japanese subjects, a sponsor will need to take into account various factors, including:

  • Company structure and culture
  • Safety record
  • Track record
  • Approaches to recruitment such as advertising, attraction and retention
  • Safeguard against over-volunteering

Company Culture and Structure

The appropriate company culture and infrastructure is very important to both subjects and sponsors who are considering participating in a bridging study, especially for the first time. A good CRO understands this and is able to ensure that their staff is trained appropriately such that they can deal with various populations. Their staff should also be able to understand small but sometimes very important nuances that demonstrate that the CRO is able to successfully integrate within the target population. A company that is involved in conducting clinical trials that involve Japanese subjects can only be taken seriously if they place the appropriate amount of significance on bridging the cultural gap.

The clinical trial environment subjects are entering is naturally foreign to them, especially if this is the first trial they have made a decision to participate in. Such an environment can be even more daunting for Japanese subjects, and it is therefore imperative that the CRO ensures a cultural blend within its employees, which will enable it to meet its volunteer’s needs. This blend must be evident through the entire company, originating from the first point of contact (within the marketing branch) that a potential Japanese subject has with the CRO, through to its interaction with clinical staff and subject recruitment agents.

A good way of easing initial concerns that a Japanese subject may have about becoming involved in bridging studies (clinical research) is by ensuring that the company has a core group of well-trained professional Japanese employees. The presence of such employees in all facets of the company serves as extended infrastructure to the Japanese subjects and helps to cement the bond of trust that is necessary for success in specialist research.

When searching for a good indicator of how well a CRO has performed in appropriately integrating itself within the target recruitment population, you don’t have to look any further than their repeat rate of Japanese trial participants, along with the extent to which previous trial participants recommend friends and colleagues to participate in a trial with a CRO. This is easier to achieve with an inbuilt Japanese infrastructure within the CRO, as it serves as a demonstration to existing and potential Japanese clinical trial participants of the importance of these subjects to new drug development within the Japanese population demographic. Moreover, such an inbuilt culture and infrastructure, when combined with the trust that must be worked on continuously, routinely translates into a CRO on which sponsors can confidently depend.

One such Clinical Research Organisation based in the United Kingdom is Richmond Pharmacology who has conducted over 50 successful bridging studies on Japanese and Caucasian subjects. If you would like to learn more about bridging studies, please visit www.bridgingstudies.com

How and when do a PAP test

Wednesday, May 11th, 2011

pap test

The Pap test means a test which all gynecologic women of childbearing age and after menopause should have regular, this after discovering that it is extremely effective as a means of prevention against cancer of the uterine body.

The PAP test is a test performed by a gynecologist absolutely not obligatory for women, whose importance as a means of preventing cervical cancer is now undisputed. This tumor is known for sure that caused by a viral infection or by a virus transmitted through sexual contact, papillomavirus (HPV).

The first conventional PAP smears should be done after the age of 18 (the period in which is supposed to have initiated the first sexual intercourse), continuing until the age of 35 years with at least once a year (this is the band’s age of increased incidence of suspicious cell changes); between 35 and 65 years can lower the frequency of checks every three years, after 65 years, this survey is used mainly to assess the state of the mucosa. (more…)

First Aid: Burns

Wednesday, April 13th, 2011

Burns are injuries to the tissues by heat. Here we will explain what to do to act on them or become nervous or frightened. There are three types of burns. The first degree, affecting the epidermis and the skin reddens.

burn injury

The second level are those that affect the skin by two layers (dermis and epidermis). It causes pain and blisters. And the third level occurs when the skin is charred. Affect all layers of skin, muscle and even bone, forming a crust as a result of destruction of tissue called eschar.

What we do with the Burn?

In minor burns:

  • Cool the burned area with cold water for several minutes.
  • Apply talc, oily liniment or ointment burns.
  • Cover the burn with sterile gauze (if we let it be very mild air), changing the cure at 48 hours.
  • (more…)

Benefits of Acupuncture

Saturday, February 5th, 2011

acupuncture

While many may be skeptical, the fact is that acupuncture is a very effective remedy for pain. To insert needles in our skin, the body releases endorphins that help to soothe the pain. Improvement is usually noticed after the first session. Despite the respect that can cause the needles, the fact is that the technique is painless and only seen a slight tingling.

The human body has different routes and channels through which energy flows. Inserting needles at these points the function of regulating energy channels, which improves the flow of this energy and disease and pain are gone. In our body there are more than a thousand acupuncture points, to combine and produce different results. (more…)

How to diagnose breast lumps

Monday, January 17th, 2011

Self exploration is one of the first steps you can take a woman to prevent, because prevention is the main weapon which has to fight against any disease. On this occasion, from this article we wonder how to diagnose breast lumps.

breast lumps daignose

Obviously it is the doctor who must make the appropriate diagnosis. Therefore, the recommendation is do you go to the specialist as soon as you miss a lump in the chest, as a priori, it is not easy to distinguish between benign and malignant lump, so it is necessary for breast examination an expert or making some technique such as MRI or mammography. (more…)

The importance of cleanliness in areas at risk in health facilities

Thursday, December 2nd, 2010

Hospitals are places that require extreme cleaning and disinfection of all clean rooms to avoid any kind of infection among patients. Cleanrooms are specially designed spaces for low levels of contamination. These areas must have controlled parameters such as air particulates, humidity, air pressure inside, lighting and temperature to avoid the risks of infection.

clean hospital

Depending on your level of risk, high, medium and low, and personal hygiene requirements will be much more specialized. High-risk areas are intensive care units, a prelude to operating rooms, operating rooms or areas of hemodialysis … should be cleaned and disinfected as a whole and very often, several times a day, after treatments, operations, etc. (more…)

Color therapy, balance and harmony

Friday, June 18th, 2010

Long before science itself recognized the great influence of the ultraviolet and infrared rays on our bodies, and there were therapists who provided treatment to their patients through the colors.

color therapy

Both in Egypt as in India and China since ancient times people knew about the healing properties of colors and applied in various ways. These cultures also used the colors in various fields of architecture, such as precincts of the temple of Heliopolis were designed so that the sun’s rays defragmented achieved in the seven colors of the spectrum, making it useful for healing.

In general, who applied this type of alternative therapy use multiple tools in combination, as are the rays of light, solarized water, food choices, taking into account the color, the clothing and the color in each room. (more…)

Calcium (CA)

Thursday, November 12th, 2009

Blood calcium is available in the free and partly linked to bicarbonate, the citrate and phosphate.
The skeleton is an important reservoir of calcium for the body, it can be removed due to parathyroid hormone, or it may be deposited as vitamin D3.
The normal value in blood is: 8.1 – 10.4 mg / dl
Normal value: in the urine (calciuria) is: 50 to 400 mg/24 h.
The decrease in calcium is caused by:

  • Hypoparathyroidism
  • Reducing the amount of magnesium
  • Reduced food intake
  • Liver disease
  • Kidney disease
  • Intestinal diseases
  • Diarrhea
  • Supply of low-fat
  • Deficiency of bile salts
  • Bone metastases
  • Acute pancreatitis.

Clinical signs of decline are:

  • Low sensitivity in different parts of the body
  • Painful muscle spasms
  • Generalized Seizures
  • Abdominal cramps
  • Spasm at the level of the larynx (choking)
  • (more…)

Cell exfoliation

Wednesday, November 11th, 2009

Are epithelial cells of the urinary tract and are present in normal conditions.
Indices of renal disease are:
the presence of particle (red and white) the presence of cylinders that is taking this aspect of training because they reproduce the mold of the renal tubule, consisting of a glycoprotein produced by the renal tubule.
It in regard to distinguish different types of cylinders:
hyaline formed only glycoprotein, generally do not have clinical significance, may occur after physical effort, general anesthesia, febrile illness.
Wax formed by proteins and lipids, and their presence may be a sign of kidney disease. (more…)

Formula leukocyte

Saturday, November 7th, 2009

Establishing the characteristics and the number of different types of white blood cells or leukocytes, are recognized in this connection:
Neutrophils, a decrease can be interpreted as bacterial infection, viral (hepatitis, infectious diseases of childhood, influenza, mononucleosis), malnutrition or alcoholism.
An increase may indicate infection with streptococcus bacteria or certain fungi.

Normal value: 50-70
Basophils: a decrease can be caused by prolonged treatment with cortisone or during pregnancy, but may be a sign of:
Thyroid disorders
urticaria
Asthma – Hay Fever
An increase is usually caused by:
anemia
Diabetes
Tuberculosis
Leukemia (more…)

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