There are many, many options to choose from if you want to get rid of the unnecessary hairs in different parts of your body. From your mustache to extra hair in your backside, there’s surely a method that would be simply perfect for your time, finances and needs. Welcome to the exceedingly variegated world of hair removal.

1. The Power of Bleaches

While it’s not hair removal per se, you can easily use chemical bleaches to camouflage those unsightly hairs. The usual problem with extra hair is that they tend to draw attention to themselves. You can either use bleach like hydrogen peroxide or skin lightening treatments for this option. The effect would be quick if you’re using hydrogen peroxide; the hair would turn to a blond hue quickly. However, make sure you don’t touch your hair if your hands have the stuff; you can easily botch your hair.

Bleaching does not necessitate you to trim or shave off the beard or mustache. The facial hair would only be following a color that is more apt for fair skin tones (this method applies well only to people with fair skin).

2. Depilatories

You’re not stuck with shaving; in fact, you can buy depilatories if you want naturally/ synthetically derived chemicals to do the hair removal for you. But make sure you get a quality depilatory cream or ointment; some ingredients may cause irritation to the skin. You wouldn’t want an allergy just because you want to remove extra hair. Take note that different creams have different “staying” times.

Read the instructions carefully and apply only the recommended amount. In addition, don’t leave the cream, lotion or ointment on too long! If the medical literature states that the product should only stay on your skin for 5 minutes, wash it off after 5 minutes. This would ensure your skin’s safety. The results of different products vary as widely as the people who buy and use them. Don’t expect too much, especially if it’s your first time to use one.

3. Plucking It Off

Like all mechanical depilation methods, plucking off the hairs has its own peculiar set of benefits and disadvantages. The main benefit is that you have complete control of the hair removal process and you’re not spending a dime more on unnecessary skin products.

The downside is that you cannot pluck wide swaths of skin (such as chest hairs and back hairs) and if you pluck too much, the skin ends up with a goose pimple appearance. This applies especially to the armpits and the chin area; some men like plucking off their chin hairs than shaving them. If you’re not gentle enough, you might end up with goose pimple-like formations on your chin, too.

Is there a way to halt the formation of the hair? Fortunately, yes. If the tweezing becomes habitual through the years, you just might cause enough selective damage to the root hairs to cause a permanent cessation of new hair growth. However, we’re not saying that you should get your metal tweezers and start poking your skin. Leave your skin be and let nature take its course.

As prescriptions medications become more expensive, Americans are looking at ways to save money. In fact many individuals are exploring many options to buy low cost medications including purchasing generic medicines. Generic medicines are generally a good buy. If you purchase generic medicines in the US, then they are FDA approved and have the same potency as the brand name medications.

Another strategy is Buying Prescription Drugs Online. There are many reputable on-line pharmacies that offer low cost medications, They will typically have low cost generic drugs. However, you should always perform your due diligence and consult with your doctor,

You may also wish to have your local pharmacists review your list of medications as well. The pharmacist’s valuable services are free and he just may discover something that your doctor may have overlooked. Don’t hesitate to ask your pharmacist questions concerning your drugs and their usage.

Another way that you can often save from 20 percent to as much as 50 percent on your prescription drug purchases is to order any required low cost medication by telephone. Many pharmacies will have reduced rates for monthly subscription plans. The drugs will be ready for your pickup and no extra trips would be necessary to the pharmacy.

To start you should make a list of all your needed medicines. List the required strengths and the number of times taken daily. Have all the related information readily at hand. Then you should call about 6 different pharmacies in your local area and request prices on the various medications. This will allow you to compare the costs associated with each pharmacy.

Never underestimate the benefits of the discount mail order sources as well. These can be very good sources to obtain your low cost medications.

It’s up to you to keep track of the medicines ordered by your doctor. You should keep a good record of your prescription medications.

Another point worth mentioning is that you should monitor the medications that your doctor has prescribed for you. If you notice duplication in your prescribed medications you should request further explanation from your doctor. As a patient you have the right to verify the need and dosage of the medicines you are prescribed.

Hemorrhoids are never fun to have. They can cause pain, discomfort, as well as itchiness. If they are on the outside, they are unsightly to the eyes. No one should have to continue suffering with hemorrhoids. The question is, does Venapro Hemorrhoid Treatment really deliver the relief that it says

Product Review The Venapro Hemorrhoid Treatment is very popular on the market as a treatment option for hemorrhoids. It offers a remedy for pain and discomfort caused by hemorrhoids. Its suggested that you will have smoother bowel movements and less constipation, which are the main cause of hemorrhoids.

The ingredients that it contains are natural and work to relieve itching, pain, and swelling that are symptoms of hemorrhoids. All of the ingredients should offer the customer immediate relief from the inflammation that they experience from the hemorrhoids. Additionally it suggests an acceleration and repair to any torn or damaged tissue.

Ingredients Inside of the Venapro treatment there is a powerful combination of natural ingredients known for their success. Witch hazel helps to strengthen the veins, as well as relaxes them. Cascara Sagrada works to aid the body in the production of bowel movements, which in turn are softer. Butcher’s Broom helps to relieve constipation, as well as pressure, and additionally works to prevent swelling. Horse Chesnut helps to reduce the swelling and itching caused by the hemorrhoids.

The Advantages

Has a proven past history of success with many people

Offers fast and effective relief

Natural ingredients

May use as preventive, as opposed to treatment only

Offers full money back guarantee

No known side effects

Free information offered on the causes of hemorrhoids and how to prevent them

Helps to restore normal blood flow to the rectum

Comes with two free bottles for a limited time

Disadvantages

No visible testimonials on their site

Does not tell customers to make sure that they do not have any kinds of allergies to ingredients and claims that there is no allergies since they are natural ingredients

Conclusion The product overall appears as a good quality product. It is a definite benefit to have two free bottles as well as a complete full money back guarantee. One thing that the site does lack is customer testimonials. In addition, they should not put that there is no allergies to their product since it is natural. Peanuts are natural and who knew that kids would no longer be able to bring peanut based foods to school, due to allergies to something that are natural. Personally, it is always to say that there are no known allergies due to things like this.

Patient Opinion Leader (POL) is one more jargon floated by pharma marketeres. And lot of people are jumping into the bandwagon too early. Let’s face it. Presently in India, POL does not exist and we can comfortably assume that POL will not have any significant impact in forseable future.

Firstly, let’s start with “Patient’s Opinion”. Here we are talking about patient’s opinion on Rx medicine. (POLs or whatever you may call it, can influence personal medical testing devices category - for example, which glucometer to buy). We must accept the fact that patients are merely a consumer who have almost no say in deciding which Rx medicine is appropriate for him/her. It is entirely doctor’s prerogative because patients are not equipped with medical knowledge to make the right choice. We may argue that today’s patients are well-read, net savvy, health conscious consumer but still patient’s opinion should not or rather can not directly impact the sale of the brand. At the most, patients’ can share their personal experiences about managing a disease which might be helpful to other patients, but their opinions cannot be taken into consideration when it comes to buying Rx medicines. And that’s why POLs, if at all they exist, cannot be given equal importance as KOLs and pharma marketers cannot afford to limit the role of Doctors.?

Moreover, patients need a platform to voice their opinion to become “Patient as a Leader. The so-called Health 2.0 or Pharma 2.0 provides a convenient platform in terms of blogs and social networking websites. Internationally, there are websites like Patientslikeme.com (featured as Disruptor of the Month by Forbes, March issue) and Six Until Me (a popular diabetes blog started by Kerry Morrone) that provide the right platform to share patients’ views, to discuss treatment options, etc. In India, we don’t have such websites but soon we might see similar websites catering to health conscious netizens.?

We should know that giving opinions on topics like movies, cars, consumer durables, etc. is fine, but when it comes to giving an informed opinion on health realted issue, one must be very careful. For example, when reports suggested that lithium might slow down the progression of ALS - a neurodegenerative disease, a number of ALS sufferers among the PatientsLikeMe community began their own somewhat impromptu drug trial, taking lithium and posting the results. Although the website has not run a formal trial and only facilitates members reporting of their results, there still has been some controversy. Such incidences can be disastrous. We must understand that leaders have followers. When it comes to treating disease, it’s advisable to follow a physician than a POL. In a nutshell, POLs, a non-medical professional who inspire trust and acts as guide to other patients, can create lots of controversies and that’s not good news for pharma marketer.?

There is no denying that internet is going to play a very important role. In US, 59% of the patients turn to internet as their first source of health information. Same might be true for India. Pharma companies are already using internet to provide information to patients. Patients are connecting with each other on the net, but at the same time I believe as far as serious medical ailment is concerned, patients are aware that there is a difference between sharing experiences on the net and taking decision based on those opinions.?

The Indian Pharma Marketer should also ask himself whether he would like to empower patients to an extent that the ‘empowered’ patients start questioning doctors or interfering with doctors’ prescriptions. The answer is a big NO, because no pharma company would like to take that risk of offending doctors. We know what happens when you turn a prescriptive brand into OTC brand and start directly promoting it to patients/consumers. That brand might increase overall sales but it surely looses out Doctors’ prescription.

On a lighter side, I have a different theory on the evolution of Patient Opinion Leaders concept. I believe the POL concept is promoted by pharma marketers who hate doctors, because no matter what innovative, out of the box, disrutptive marketing strategy they implement, but ultimately the fate of prescriptive brands are in doctor’s hand and in most cases, the KOLs decide the success or failure of the brand. Therefore frustated pharma marketers want to counter KOLs by creating another equally powerful monster called POLs. Don’t forget guys, a monster is a monster is a monster.

It is very important you know all you can about your new prescription. It is only through knowledge that you will get the largest benefit from any medication.

You must take an active role in your health care. You should have a team like approach with your physician, nurses, dietitians, respiratory therapists, and pharmacist playing supporting roles.

When you are given a new prescription you should ask the following questions:

1. What is the full name of the prescription Is there a generic name for this medication

2. What does this medication do

3. Can I take a generic version of this medication (they are less expensive)

4. Will the generic version do the same things as the brand name medication

5. What is the dose

6. When do I take this medication

7. What do I do if I miss a dose

8. Can I take this medication with food Grapefruit juice

9. Are there any foods I should avoid while taking this medication

10. What are the side effects of this medication

11. What should I do if I experience any of these side effects

12. If I should take more than the prescribed dose (accidently of course), what should I do

13. Will this medication interact with any other prescription medications I am taking

14. If I take an over-the-counter (OTC) medication will it affect my new prescription

15. Are there any information sheets I can take home with me about this medication

16. If I cannot afford this medication, are there any resources available that will help me get my medication

Mild Arthritis can be tackled by topical remedies. If you do not take oral medication then a topical pain reliever is right for you! All you have to do is rub a lotion or cream on the troublesome spot and your pain will be relieved in minutes.

Topicals are based on 3 main active ingredients. The first is capsaicin, this substance is found in hot peppers it works by blocking pain signals to the brain. This product lowers your level of substance P (the substance that relays pain impulses). You need to apply this type of cream a few times a day for a few weeks to see results.

Next is counter irritants, these substances are able to relieve pain telling the body to feel coolness or hotness instead of pain. This distracts the joint pain and you are left with temporary relief. These products may cause a slight redness and usually works the best on joints that are near the surface of your skin, such as elbows, fingers, ankles and knees.

Last is salicylates and this works by decreasing the pain and inflammation. This substance is almost like an aspirin that you rub on your skin. If you are allergic to aspirin make sure you check for a topical without salicylates.

Make sure you wash your hands before you apply any type of medication to relieve pain. If your skin is cut or broken avoid contact with that area it will burn. Also make sure you always avoid contact with open areas such as mouth, eyes, and nose. If you enjoy working about do not apply arthritis cream before you exercise because if you perspire your body will absorb too much of the substance into your blood stream.

Arthritis is a disorder of the joints; its main feature is inflammation. Joints are used to move your body parts. There are many types of arthritis. Some have little pain and other can be so excruciating you can not even move your joints without medication.

About 350 million people have some form of arthritis. These people range from men to women and children to elderly. There are over 100 types of arthritis. The symptoms can expand from just the joints to health problems as well. You can have weight loss, fatigue, fevers, and glad swelling. Symptoms associated with just the joint can be stiffness, swelling, warmth, or redness.

Women are more likely to have arthritis than men. About 60 percent of the people who have arthritis are under 65. It is very important that you catch and treat arthritis at an early stage. You need to see a doctor as soon as you feel your joints are hurting for no reason. If you attack this problem at an early stage you are more likely to create a treatment plan and not have the pains that you would later.

Help relieve your pain with this awesome topical product called Painful Joints. This product targets arthritis patients and instantly removes pain. Treat your arthritis early and avoid future pain.

1. Carrying case: A small plastic toolbox would do as it is light, portable and affordable.

2. First aid book

3. Petroleum jelly (Vaseline) Pack this to lubricate the rectal thermometer.

4. Calamine lotion - This is great stuff to relieve the itching of poison ivy and bug bites.

5. Diphenhydramine (Benedryl) - An antihistamine helpful in handling any minor allergic reactions.

6. Antibiotic ointment - Good for certain cuts that are at risk for infection. If a cut or scrape appears to be infected already, consult the doctor before administering the antibiotic ointment.

7. Self-injectable epinephrine - This is a prescription medication limited to those at risk for life-threatening allergic reactions from bee stings, certain foods, etc.

8. Tweezers - These are essential for removing ticks, splinters, etc.

9. Small flashlight (don’t forget extra batteries).

10. List of important phone numbers - (doctor, friend or relative).

11. Painkillers such as acetaminophen, paracetamol or ibuprofen - (these medications are not only for fever but also are good for pain control).

12. An accurate measuring device - i.e. syringe or spoon.

13. Gauze, adhesive tape, bandages and plasters, in a variety of different sizes and shapes.

14. Small sharp scissors - These will be needed to cut the tape, gauze, or whatever.

15. Alcohol pads

16. Thermometer

17. Sterile eye dressing

18. Safety pins

19. Disposable sterile gloves

20. Alcohol-free cleansing wipes

21. Thermometer, preferably digital

22. Skin rash cream such as hydrocortisone or calendula

23. Cream or spray to relieve insect bites and stings

24. Antiseptic cream/ointment

25. Cough medicine

26. Decongestant tablets or nasal spray

27. Distilled water, for cleaning wounds and as an eye bath

28. Anti-bacterial gel for hand washing without water

29. Insect repellent

30. Sunscreen

31. Pre-moistened towelettes (i.e. babywipes)

32. Tissues

33. Anti-diarrhoeal

34. Antacid

35. Cough medicine and/or throat lozenges

36. Petroleum jelly

37. Cotton balls and/or swabs

38. Antiseptic soap

39. Lotion for diaper rash

40. Teething medicine

41. Nasal aspirator for baby

42. Ice Packs (used to help reduce swelling).

43. Steri-Strips: (also known as Butter-Flys, Adhesive Sutures, Adhesive Closures).

44. Neosporin/Bacitracin Ointment (this is a topical antibiotic)

45. Cortisone Ointment. This is especially helpful with any contact dermatitis (i.e. poison ivy, oak)

46. Benadryl tablets (antihistamine - control allergic reactions)

47. Eye wash

48. Forceps: 1 pair disposable splinter forceps

49. Mouthwash.

In the Type 2 form of Diabetes the pancreas produces insulin but the body is not able to use the insulin produced either partially or completely. The other term that can be used for this is insulin resistance and this is the main cause for the development of Type 2 diabetes. The body makes every effort to produce more insulin to overcome this resistance and when it fails to cope with the higher demands Type 2 Diabetes is the outcome. Heredity also plays a major role in Type 2 diabetes. Let’s look at a few causes these are, high blood triglyceride levels, high blood pressure, high fat diet, gestational diabetes, high alcohol intake, obesity ( especially around the waist region), sedentary lifestyle and ageing.

It can take a very long time maybe even several years for the blood sugar level to indicate a potential threat of Type 2 diabetes. Quite often the symptoms are not very obvious or evident at all. Sometimes it is discovered accidentally during routine checkups and or when a person is being screened for another condition. Symptoms that can be seen are unusual thirst, tiredness, blurred vision, loss of weight, increased urination, infections such as thrush or an irritation of the genitals, frequent or slow - healing infections, erectile dysfunction, increased appetite, severe gum problems, unusual sensations especially in the extremities, and itching. In the case of children the symptoms are often different as in most cases children are obese and overweight, many children develop a skin problem called acanthosis covering the skin with dark, velvety patches and increased urination is mild or even absent.

Most often Type 2 diabetes can be controlled by lifestyle changes alone. A strict and healthy diet is to be maintained. This is very much the same as a normal, balanced diet that is recommended for good health i.e. foods that are low in saturated fat, high in fiber, vegetables and fruits, sugar and salt. Weight needs to be kept under control to avoid risk of cardiovascular disease. Exercise is necessary as this increases the body’s response to insulin, exercise should be done at least five days a week. Smoking is to be strictly avoided. Alcohol can be had in very small quantities though. In case lifestyle changes don’t reduce glucose levels then your physician may prescribe the required medications. For some if lifestyle changes or medication does not help in controlling blood glucose levels then there is a probability that insulin injections have to be started. This could be temporary or for a longer period of time. These injections are in most cases self administered as per requirement. Insulin differs and works for different periods of time and at different rates. And lastly blood sugar levels can be monitored by an individual with a home test kit.

Having read the above information I hope you have gained some valuable knowledge. Much of how you progress depends entirely upon yourself. Lack of discipline to apply knowledge gained will be regretted so it is better to put it into motion and know the results for yourself. A positive attitude is the way to go.!!

Drink lots of water because it is calorie free and helps to flush away the toxins. Did you know that flavored carbonated water has no calories, sugar, body, sweetener, color or preservatives?

Want to know more about carbonated flavored water?

Check out http://carbonatedseltzerwater.com

Overcome Snoring Once and For All

Think of It: Having to sleep in the same bedroom with a snoring husband or wife, night after night. The funny thing is that most people who snore not at all agree that they do. Imagine each and every night you’re awake in the middle of the night listening to this. It is amazingly frustrating knowing that you have to get up in the morning and you can’t fall asleep.

‘They’ believe it is just a common condition that most men have. ‘They’ can believe what ‘they’ want to believe. ‘WE’ want to do something about it! And fortunately we CAN.

What is snoring?

Snoring happens as soon as the flow of air from your mouth or nose to your lungs makes the tissues of the airway vibrate. Most of the time this is caused by some sort of jam or obstruction is the nose, mouth, or throat, but the cause generally varies from case to case. Snoring is devastating to quality sleep. The cause for snoring and solutions are addressed. Snoring has long been thought of as simply an aggravation for the bed partner but in recent years much has been learned about the real dangers that snoring indicates. The concrete sound known as snoring is caused by the vibration of the walls of the throat. Most people might think it as a nonsense issue to even talk about. Snoring may increase with age. Snoring can affect you and your partner in many ways, including sleep disturbance, tiredness, exhaustion, and lack of concentration. A permanent lack of sleep and the consequential frustration can lead to strained relationships.

Types of Snoring

- Snoring while sleeping for the duration of night times only, this condition of snoring is what usually is called the usual snoring habits - Snoring while sleeping any time of the day - Snoring while mouth closed shows a problem with the tongue - Snoring while mouth is open shows a problem with the throat - Snoring when lying on your back shows a mild difficulty - Snoring when sleeping in any positions shows the problem is serious

Controlled and Uncontrolled factors of snoring

It is general believe that there are things that we can control and those that we cannot control when it comes to snoring. Fortunately we know better these days. For example: Snoring when your back is lying on the bed, most commonly indicates exhaustion. It could be that the back of the tongue is blocking some parts of the passage ways and causes the sound that produces the snoring.

What to do when you are snoring severe? Is it DANGEROUS?

If you’re snoring in your sleep in any kind of sleeping posture of position, then it is considered as serious. If you snore, you may wish to talk to your doctor. As said: Snoring happens when the passage of air through the mouth and nose is physically blocked. It is the vibration of respiratory structures and the resulting sound, due to blocked air movement during breathing while sleeping. Snoring can actually lead to a condition called sleep apnea, which occurs when a person ceases breathing during sleep. While snoring doesn’t automatically lead to cases of sleep apnea, it is a risk; and snorers are thus advised to consult with their physician to see if they can pro-actively cut down on some risk factors. Medicines can help as well, but being careful of what you do, what you eat, and your actual lifestyle will affect you tremendously. And it is also very well doable to “cure” snoring Naturally.

Clinical trial sponsors can collect patient reported outcomes electronically in multinational clinical trials. Advantages include significant improvements in clinic and subject compliance, data quality, data access and monitoring, as well as reduced staff and subject burden. Yet, ePRO clinical solutions can also present challenges. By understanding some important ePRO best practices, however, sponsors can overcome major challenges.

ePRO CLINICAL SOLUTIONS: BRIEF SUMMARY OF THE CHALLENGES

One of the major challenges faced when using Electronic Patient Reported Outcomes (ePRO) in multinational trials is ensuring the quality and reliability of the ePRO systems and data files. After all, even small problems with the systems or data can sometimes damage credibility, which can lead to decreased system usage, increased enrollment, queries, and other trial costs, and at worst, the discrediting of all the data.

Another challenge is the very large number of changing variables that need to be managed. These variables include:

- Complex protocols and lengthy questionnaires

- Long lists of countries, languages and translations

- Complex system requirements

- Interdependent schedules

- Long growing lists of issues

- A multitude of first patient dates

- International user support across different time zones in many languages.

Validity, or measurement equivalence with validated paper questionnaires, can also be a significant challenge. Due to the nature of the hardware and software, some systems cannot fully support existing validated paper questionnaires.

For instance, small hand-held devices generally have very restricted screen real estate. IVR systems are limited because subjects can only remember short questions and answers. In these and other cases, the questions and answers from a validated paper questionnaire often have to be modified in order to accommodate the technology.

In order to then ensure that the data from the electronic systems are equivalent to the paper-based questionnaire, it is often necessary to conduct a validation study comparing the data collected on the new electronic tool with the data collected on the validated paper questionnaire. These validation studies can add significantly to both costs and project timelines.

Finally, a challenge faced by many when using Electronic Patient Reported Outcomes in multinational trials is quality assurance and auditing. Some auditors have limited experience or knowledge of ePRO systems, leading to varied interpretations of industry regulations. These diverse regulatory interpretations can cause confusion, and also have considerable cost and timeline implications.

ePRO CLINICAL SOLUTIONS: BEST PRACTICES

The challenges described above sometimes appear daunting to a study team, even though they appreciate the potential. However, there are solutions. The best practices described below offer a method to manage the challenges.

ePRO CLINICAL SOLUTIONS: SYSTEM QUALITY AND RELIABILITY

All successful systems start with an unambiguous systems requirements document. The purpose of this document is to describe the system(s) to be delivered in detail, so that all team members have exactly the same expectations of what the system will do and what data the system will provide.

The process of writing and reviewing a detailed planning document, whether it be systems requirements, a clinical trial protocol, or otherwise, forces the author and the reviewers to think through options for processes and to discuss and tweak them until there is confidence among all participants that the best solution has been designed.

So, the systems requirements definition process, properly executed, produces quality thinking on system design and is the first step towards producing quality systems. In addition, because the deliverable is a written detailed document describing how the system will work, it prevents misunderstandings, confusion and frustration at a later stage when the systems are implemented.

A systems requirements document must show all screen shots exactly as they will look in the completed system. Every edit for every data entry field, all screen and system validation checks, and all system logic (skips, conditions, calculations, error conditions, messages, and so on) must be described clearly and in detail.

This documented presentation of the system both ‘on the surface’ and ‘beneath the surface’ (logic checks, and so on) enables the sponsor team and the ePRO provider to think about the issues carefully before programming starts. It will also make certain that the system design will ensure compliance with protocol, and that the resulting data files will meet the needs of the study.

The final systems requirements document must be signed by the key sponsors and ePRO provider team members, to show agreement and commitment from both parties on the details of all systems functions and operations. When evaluating providers, the sponsor should ask to see systems requirements documents from previous projects.

The sponsor should ensure that the providers have the skills to deliver a thoughtfully prepared systems requirements document which describes a high quality system with the attributes the sponsor desires: ease of use, protocol compliance, data quality controls, rapid data access, and so on.

To deliver consistently reliable systems, the Electronic Patient Reported Outcomes provider must also have the skills to develop and execute high quality system test plans. Test plans must include thoughtful test cases that address every requirement in the systems requirements document.

To ensure every systems requirement is covered, there must be a traceability matrix which matches each requirement in the systems requirements document to the relevant test cases in the test plan. This may seem obvious, but it is often not done.

For each systems requirement there must also be detailed test cases and scenarios for both valid and invalid data, as well as standard and non-standard user actions. The expected results for each test must also be documented in advance of the test cases to ensure the integrity of the test. In addition, the test plan needs to include large data input sets that represent a wide variety of diverse scenarios.

Furthermore, it is vital that the test plan include significant load and stress testing to ensure that the systems will function properly in real world conditions, when an exceptionally large set of data has been collected or when stressful situations are encountered.

When executing the test plan, the testing specialists must document whether the tests pass satisfactorily and ensure that every data file is correct, without exception. When evaluating ePRO providers, the sponsor should also review test plans and traceability matrices from previous projects to ensure that the provider has the skills to develop and execute test plans that meet the standards described above.

In addition to the formal testing performed by the provider, the sponsor must also carefully review the software by performing a user acceptance test. The purpose of this test is to ensure that both the ePRO team and the sponsor team agree that all systems requirements have been implemented as described in the

systems requirements document.

If the provider has executed a quality test plan, this sponsor process should be quick and easy, and should provide the sponsor team final control and peace of mind before delivering systems for the first patient date. However, if the provider has not performed adequate testing, quality issues may be revealed and the sponsor then has the opportunity to delay shipment and require corrective action before the systems are distributed to sites and become a burden in the field.

ePRO CLINICAL SOLUTIONS: COMPETENT PROJECT MANAGEMENT

Because there are so many moving parts in multinational trials, it is critical that the provider can develop and maintain complicated project plans. Project plans must include hundreds, sometimes thousands, of detailed tasks and expected durations, dependencies between them, and contingencies for unexpected events.

Because the ePRO project schedule typically involves hundreds of tasks, the provider must demonstrate competencies with an electronic project management tool so that a changing environment can be accommodated quickly. During the provider evaluation process, sponsors should also look at project schedules and project status reports from previous studies to help determine the providers’ project management skills.

In addition, good communication among the project team members needs to be the rule and not the exception. Regularly scheduled project management team meetings with key staff from both the sponsor and the provider are critical to review the status of project tasks, determine if changes are needed, and to resolve any issues that arise. These project status meetings are crucial in order to ensure that sponsor and ePRO team member efforts are complementary and effective.

ePRO CLINICAL SOLUTIONS: CHOOSE SYSTEMS THAT SIGNIFICANTLY REDUCE VALIDATION ISSUES

To resolve the challenge of measurement equivalence between a validated paper questionnaire and an electronic device, sponsors can choose a technology where the validated paper questionnaire text does not need to be changed. Touchscreen tablet or internet-based systems typically offer this kind of flexibility.

Although it is beyond the scope of this article, the validation requirements for these technologies are very minimal.

ePRO CLINICAL SOLUTIONS: MANAGE QUALITY ASSURANCE AUDITORS

Given that many auditors have little experience with Electronic Patient Reported Outcomes, sometimes their statements can be confusing, and even frightening.

If an auditor imposes requirements that seem unreasonable, it is important to review the regulation(s) with the auditor and find more practical solutions. In most cases, there are various avenues to ensure regulatory compliance, and many of them are simple and cost-effective.

ePRO CLINICAL SOLUTIONS: CONCLUSION

The best practices discussed above can provide real tools for addressing the challenges that can arise in the implementation of Electronic Patient Reported

Outcomes in multinational clinical trials. While these best practices do not cover every possible situation that can occur, they will provide significant assistance in addressing key challenges, and put their clinical trials on a solid path to success.